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Muluneh B, Upchurch M, Belayneh B, Mackler E, Bryant AL, Wood WA, Boynton MH, Wheeler SB, Zullig LL, Lafata JE. Design and implementation of a risk-adapted, longitudinal, theory-driven medication adherence intervention: A protocol for a multi-phasic, hybrid effectiveness-implementation trial. Res Social Adm Pharm 2025; 21:444-452. [PMID: 39988489 PMCID: PMC11911068 DOI: 10.1016/j.sapharm.2025.02.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/12/2024] [Revised: 01/29/2025] [Accepted: 02/09/2025] [Indexed: 02/25/2025]
Abstract
BACKGROUND The increasing use of targeted oral anticancer agents (OAAs) has transformed cancer treatment, yet patient adherence in real-world settings remains suboptimal. This protocol outlines a multi-phasic, hybrid effectiveness-implementation trial designed to develop, implement, and evaluate a risk-adapted, longitudinal medication adherence intervention for patients prescribed OAAs. METHODS Drawing on social cognitive theory, intervention mapping, and implementation science, the study aims to address barriers at cognitive, behavioral, and environmental levels that impact adherence. Phase 1 identifies implementation barriers and refines strategies, informed by expert input and semi-structured interviews. Phase 2 incorporates patient-centered feedback to tailor a theory-driven intervention targeting adherence barriers. In Phase 3, the intervention is piloted across diverse clinical settings to assess its effectiveness and implementation feasibility. CONCLUSION This trial aims to deliver a scalable and sustainable model for adherence support, with broad implications for improving patient outcomes and integrating adherence monitoring in routine cancer care.
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Affiliation(s)
- Benyam Muluneh
- Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, USA.
| | - Maurlia Upchurch
- Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, USA
| | - Bethel Belayneh
- Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, USA
| | - Emily Mackler
- Michigan Oncology Quality Consortium, Ann Arbor, MI, USA
| | - Ashley Leak Bryant
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, USA; School of Nursing, University of North Carolina at Chapel Hill, USA
| | - William A Wood
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, USA; School of Medicine, University of North Carolina at Chapel Hill, USA
| | | | - Stephanie B Wheeler
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, USA
| | - Leah L Zullig
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, USA
| | - Jennifer Elston Lafata
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, USA; Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, USA
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Unal E, Cinar FI, Porucu C. Factors affecting medication adherence in patients using oral chemotherapy: A descriptive study. J Oncol Pharm Pract 2025; 31:412-421. [PMID: 38613321 DOI: 10.1177/10781552241241059] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/14/2024]
Abstract
IntroductionThe utilization of oral chemotherapy agents for cancer treatment has witnessed a steady rise in recent years. The pivotal determinant for the success of oral chemotherapy lies in the adherence of cancer patients to the prescribed treatment. This study aims to explore oral chemotherapy adherence and identify factors influencing medication adherence among cancer patients.MethodsA total of 103 cancer patients participated in this descriptive study. Data were collected using the Oral Chemotherapy Adherence Scale, the Turkish Translation of the Beliefs about Medicines Questionnaire (BMQ-T) and The Functional Living Index-Cancer.ResultsOf the participants, 66% reported good adherence to oral chemotherapy. Key findings indicate that access to health services (β = -1.473, p = 0.009), cancer stage (β = -1.570, p = 0.015) and the BMQ-T subscale of General Overuse (β = .696, p = 0.041) were independent predictors of medication adherence.ConclusionThe study observed medication non-adherence in one-third of patients undergoing oral chemotherapy. Primary contributors to non-adherence included difficulties in accessing health services, advanced cancer stage and the belief that drugs are over-recommended by doctors. These results underscore the need for a heightened focus on preventable factors, such as improving access to health services and addressing beliefs about drug overuse, to enhance medication adherence in patients receiving oral chemotherapy.
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Affiliation(s)
- Eda Unal
- Faculty of Health Sciences, Kırşehir Ahi Evran University, Kırşehir, Bağbaşı, Turkey
| | - Fatma Ilknur Cinar
- University of Health Sciences Turkey, Gülhane Faculty of Nursing, Ankara, Turkey
| | - Canan Porucu
- University of Health Sciences Turkey, Gülhane Training and Research Hospital, Ankara, Turkey
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Omran MM, Ibrahim AB, Abdelfattah R, Moussa HS, Shouman SA, Hamza MS. The interplay of knowledge, motivation, and treatment response in medication adherence among patients with chronic myeloid leukemia treated with Imatinib. Leuk Lymphoma 2025; 66:123-130. [PMID: 39291898 DOI: 10.1080/10428194.2024.2403671] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Revised: 09/03/2024] [Accepted: 09/07/2024] [Indexed: 09/19/2024]
Abstract
Chronic Myeloid Leukemia (CML) requires consistent medication adherence to Imatinib (IM) for optimal outcomes, however, adherence to oral chemotherapy is challenging. This observational study explores the relationship between patient knowledge, motivation, and adherence to IM therapy, and their collective impact on clinical outcomes. A prospective, observational study was conducted with 101 CML patients. The 6-Item Morisky Medication Adherence Scale (MMAS-6) was used to assess adherence, motivation, and knowledge levels. The study found that high motivation was significantly associated with lower BCR-ABL expression (p = 0.025). Patients with high knowledge and motivation had a 71% favorable response rate, compared to 0% in those with low knowledge and motivation (p = 0.01). As conclusion both patient motivation and knowledge are crucial for favorable treatment outcomes in CML. High levels of both significantly correlate with better clinical responses. Tailored interventions to enhance patient knowledge and motivation are essential.
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Affiliation(s)
- Mervat M Omran
- Cancer Biology Department, Pharmacology Unit, National Cancer Institute, Cairo University, Cairo, Egypt
| | - Amel B Ibrahim
- Department of Pharmacology, Faculty of Medicine, Zawia University, Az-Zāwiyah, Libya
| | - Raafat Abdelfattah
- Medical Oncology Department, National Cancer Institute, Cairo University, Cairo, Egypt
| | - Heba S Moussa
- Clinical Pathology Department, National Cancer Institute, Cairo University, Cairo, Egypt
| | - Samia A Shouman
- Cancer Biology Department, Pharmacology Unit, National Cancer Institute, Cairo University, Cairo, Egypt
| | - Marwa S Hamza
- Clinical Pharmacy Practice Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo, Egypt
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Badiei Moghaddam S, Rakhsha A, Siavashpour Z. Permanent alopecia after radiotherapy of primary brain tumours: The most influential factors. Cancer Radiother 2024:S1278-3218(24)00154-9. [PMID: 39578138 DOI: 10.1016/j.canrad.2024.05.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2023] [Revised: 01/30/2024] [Accepted: 05/11/2024] [Indexed: 11/24/2024]
Abstract
PURPOSE Alopecia is a distressing side effect of radiotherapy in patients undergoing treatment for primary brain tumours. This study aimed to investigate the most influential clinical, demographic, and dosimetric factors associated with permanent scalp alopecia in patients with brain tumours treated with intensity-modulated radiations. PATIENTS AND METHODS Eighty patients with brain tumors treated with intensity-modulated radiations were enrolled. Inclusion criteria were having a primary brain tumour and patients with at least 18 months of radiotherapy. Scalp alopecia was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The scalp location with hair loss was marked and delineated on their follow-up MRI, and the planning dosimetric parameters, including D0.1cm3 (as maximum dose), mean dose, and various volumetric parameters such as V16Gy-43Gy (with about 5Gy interval) were recorded. In addition, receiver operating characteristic (ROC) curve analysis was employed to identify predictive parameters for chronic alopecia. RESULTS The hair loss severity was grade 1 for 70 % of cases, and grade 2 for 30 %. Male gender, history of chemotherapy, and family history of hair loss were significantly associated with increased volume of hair loss follicles. The correlation and ROC analysis revealed that regions receiving doses of 30Gy or higher (i.e., V30Gy) were associated with a higher risk of developing grade 2 alopecia. The resulting areas under the curve of 0.694 were indicators for moderate correlations between the considered dose-volume histogram parameters and patients' permanent alopecia. Even if these results were not statistically significant, these findings suggest that specific dosimetric parameters, such as V30Gy to V43Gy, maybe the strongest predictors of grade 2 chronic radiation-induced alopecia. The cut-off values were also about 13.5 to 8 cm3 for V30Gy to V43Gy, respectively, which can be played as an indicator of the dose-volume histogram threshold above which permanent alopecia will be expected after brain intensity-modulated radiotherapy. CONCLUSION The incidence of permanent alopecia after intensity-modulated radiotherapy is influenced by demographic, dosimetric, and clinical factors such as gender, history of chemotherapy, and family history, and the skull follicle regions receiving doses of 30Gy or higher.
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Affiliation(s)
- Simin Badiei Moghaddam
- Radiotherapy Oncology Department, Shohada-e Tajrish Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
| | - Afshin Rakhsha
- Radiotherapy Oncology Department, Shohada-e Tajrish Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
| | - Zahra Siavashpour
- Radiotherapy Oncology Department, Shohada-e Tajrish Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
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Saeheng T, Karbwang J, Na-Bangchang K. Population-pharmacokinetic/pharmacodynamic model of atractylodes lancea (Thunb.) DC. administration in patients with advanced-stage intrahepatic cholangiocarcinoma: a dosage prediction. BMC Complement Med Ther 2024; 24:384. [PMID: 39508255 PMCID: PMC11542380 DOI: 10.1186/s12906-024-04618-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2023] [Accepted: 08/15/2024] [Indexed: 11/08/2024] Open
Abstract
BACKGROUND A recent phase 2A clinical study of Atractylodes lancea (Thunb.) DC. (AL) in patients with advanced-stage intrahepatic cholangiocarcinoma (iCCA) demonstrated significant reduction of the risk of tumor progression and mortality with a dose ranging from 1,000 to 2,000 mg. The present study aimed to determine the potential dosage regimen of AL for further phase 2B clinical study. METHODS Plasma-concentration time profiles of total AL bioactivity and clinical efficacy in patients with advanced-stage iCCA were obtained from Phase 2 A study. The population pharmacokinetic (pop-PK) model was developed. The pop-PK model and Monte-Carlo (MC) simulation, in conjunction with maximum concentration of AL (Cmax) as a cut-off criterion, was performed and validated with clinical data. The optimal model was used to simulate further dosage regimens and clinical efficacy of AL. RESULTS The pop-PK properties of total AL bioactivity were best described by a compartmental model with zero-order absorption (without delay) and linear clearance. None of the investigated covariates improved model accuracy.The developed pop-PK with MC simulations following once-daily dosing of 1,000 mg and 2,000 mg adequately predicted the clinical efficacy (tumor progression and mortality). The once-daily dose of 2,500 mg is recommended for further phase 2B clinical study due to its relatively high efficacy on tumor progression inhibition (73%) and mortality rate reduction (71%) without excessive number of the administered capsules (23 capsules) and low risk of toxicities (<5%). CONCLUSIONS The applied pop-PK model with MC simulation, along with the appropriate cut-off pharmacokinetic parameters, can be used as a potential tool for supporting dosage prediction and selection for clinical studies, and thus reducing the rate of drug development failures. TRIAL REGISTRATION www.thaiclinicaltrials.org , WHO ICTRP search, TCTR20210129007 , Registed 29 January 2021.
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Affiliation(s)
- Teerachat Saeheng
- Centre of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), 99, moo 18, Phaholyothin Road, Klongneung sub-district, Klongluang district, Pathumthani, 12121, Thailand
- Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand
| | - Juntra Karbwang
- Drug Discovery and Development Centre, Office of Advanced Science and Technology, Thammasat University (Rangsit Campus), Klongluang, Pathumthani, Thailand
| | - Kesara Na-Bangchang
- Centre of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), 99, moo 18, Phaholyothin Road, Klongneung sub-district, Klongluang district, Pathumthani, 12121, Thailand.
- Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Klongluang, Pathumthani, 12120, Thailand.
- Drug Discovery and Development Centre, Office of Advanced Science and Technology, Thammasat University (Rangsit Campus), Klongluang, Pathumthani, Thailand.
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Prakash GH, Kumar D S, Pk K, Arun V, Yadav D. Development and validation of the chemotherapy adherence assessment scale (CAAS). J Oncol Pharm Pract 2024:10781552241291225. [PMID: 39397584 DOI: 10.1177/10781552241291225] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/15/2024]
Abstract
BACKGROUND Adherence to chemotherapy regimens is crucial for achieving optimal treatment outcomes in cancer patients. However, measuring adherence remains a significant challenge. This study aimed to develop and validate a comprehensive self-report tool for assessing chemotherapy adherence. METHODS The Chemotherapy Adherence Assessment Scale (CAAS) was developed through a multi-stage process involving literature review, expert input, and pilot testing. Face validation was conducted with 23 subject experts, and content validity was assessed using the Content Validity Index (CVI). The CAAS was pilot-tested on 28 cancer patients undergoing chemotherapy. Psychometric properties were evaluated through internal consistency analysis (Cronbach's alpha) and Exploratory Factor Analysis (EFA). RESULTS Face validation revealed 85% agreement among experts regarding grammar, clarity, and content. The CVI was 0.81 for individual items and 0.83 for the overall scale, indicating good content validity. Cronbach's alpha was 0.789, demonstrating strong internal consistency. The EFA yielded a robust five-factor structure, explaining 94.63% of the total variance. Most items exhibited strong factor loadings (>0.7) and high communalities (>0.7), supporting the construct validity of the CAAS. CONCLUSIONS The CAAS demonstrated robust psychometric properties, including good content validity, high internal consistency, and a well-defined factor structure capturing key dimensions of chemotherapy adherence. The CAAS represents a valuable contribution to adherence assessment in oncology settings, with potential applications in clinical practice and adherence interventions.
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Affiliation(s)
- G Hari Prakash
- Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India
| | - Sunil Kumar D
- Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India
| | - Kiran Pk
- Department of Medical Oncology, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India
| | - Vanishri Arun
- Department of Information Science and Engineering, SJCE, JSS STU, Mysuru, India
| | - Deepika Yadav
- Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India
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Ky TD, Loan NT, Thinh NT, Binh MT. Nonadherence to oral cancer chemotherapy in hepatocellular carcinoma: prevalence and predictive factors in Vietnam. BMC Cancer 2024; 24:841. [PMID: 39009994 PMCID: PMC11247847 DOI: 10.1186/s12885-024-12601-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2023] [Accepted: 07/03/2024] [Indexed: 07/17/2024] Open
Abstract
PURPOSE Standard oral cancer chemotherapy (OCT) or targeted therapy (OTT) has expanded the treatment methods for hepatocellular carcinoma (HCC). However, its principal nonadherence causes a reduction in efficacy. We aimed to evaluate the status of nonadherence and influencing factors among outpatient patients with HCC. PATIENTS AND METHODS In 2021, a prospective observational study was conducted on 384 patients with either old or newly diagnosed HCC treated with OTT. Nonadherence to OCT was determined using the eight-item Morisky Medication Adherence Scale, with a score < 6 points. The patients were finished with a six-month follow-up investigation by questionnaires. RESULTS 54,8% of HCC outpatients were nonadherent to OCT, with a mean Morisky score of 5.19. They dropped out of the treatment mainly because of drug side effects, such as fatigue (72.4%), hand-foot syndrome (42.7%), diarrhea (38.3%), nausea (25%), insomnia (24.7%), abdominal pain (12%), and anxiety about these adverse events (65.9%). Additionally, financial difficulties and low relative copayments were significantly correlated with the noncompliant treatment of patients (OR = 2.29, 95% CI = 1.32-3.98, P = 0.003; OR = 4.36, 95% CI = 0.95-19.93, P = 0.039, respectively). Moreover, inadequate individual information about the clinical course, the art of treatment, and medication usage instructions were suggestive barriers to adherence to treatment (OR = 1.96, 95% CI = 1.08-3.55, P = 0.024; OR = 1.86, 95% CI = 1.1-3.14, P = 0.02; OR = 2.34, 95% CI = 1.29-4.26, P = 0.004, respectively). Finally, a low level of trust in doctors was an essential factor in nonadherence (Mean of the Anderson Trust in Physician Scale scores counted 38.12 vs. 43.97, respectively for non-adherence vs. adherence, P = 0.00001). CONCLUSIONS This study suggests a high rate of primary nonadherence to standard oral targeted therapy among HCC outpatient patients because of drug side effects, patient awareness of treatment, and lack of confidence in healthcare providers. Close supervision, proper medication instructions, appropriate dosage reductions, and comprehensive patient counseling might be necessary to control nonadherence.
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Affiliation(s)
- Thai Doan Ky
- Department of Gastroenterology and Hepatology, 108 Military Central Hospital, Hanoi, Vietnam
| | - Nguyen Thi Loan
- Department of Gastroenterology and Hepatology, 108 Military Central Hospital, Hanoi, Vietnam
| | - Nguyen Tien Thinh
- Department of Gastroenterology and Hepatology, 108 Military Central Hospital, Hanoi, Vietnam
| | - Mai Thanh Binh
- Department of Gastroenterology and Hepatology, 108 Military Central Hospital, Hanoi, Vietnam.
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McNabb L, Metrot E, Ferrington M, Sunderland B, Parsons R, Copeland TS, Corscadden S, Tong S, Czarniak P. Assessment of patient perceptions of counselling on oral antineoplastic agents by a dedicated cancer services pharmacist in an outpatient cancer clinic. PLoS One 2024; 19:e0304011. [PMID: 38870231 PMCID: PMC11175407 DOI: 10.1371/journal.pone.0304011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Accepted: 05/04/2024] [Indexed: 06/15/2024] Open
Abstract
BACKGROUND Oral antineoplastic agents have caused a paradigm shift in cancer treatment, however, they produce many unique challenges. Although oral antineoplastics can have complex administration regimes, low adherence rates and high possibilities of drug-drug interactions, they are administered unsupervised at home. Cancer services pharmacists have the required skillsets to improve patient outcomes associated with oral antineoplastic treatment by increasing patient health literacy, improving concordance and optimising administration protocols. AIM To evaluate patients' perceptions, experiences and overall satisfaction with dedicated clinical pharmacist consultations in patients treated with oral antineoplastic agents at a major public hospital. METHOD In this retrospective cross-sectional study at a quaternary hospital in Western Australia, data were collected by a paper questionnaire (mailed in March 2022) to a random sample of 191 patients initiated on oral antineoplastic drugs between January 2021 and February 2022. Demographics, prescribed antineoplastic drug/s, cancer type data were collected including using 5-point Likert scale questions assess patients' overall satisfaction with the clinical pharmacist consultations. RESULTS The questionnaire response rate was 27.7% (52/188) (mean age 63.2 years; 57.5% female). Most patients (42/52; 80.8%) were satisfied with pharmacist consultations, trusted the pharmacist's advice (45/52; 86.5%), considered that the pharmacist improved their understanding of how to manage side effects (43/52; 82.7%) and they provided an important service in outpatient care (45/52; 86.5%). CONCLUSION Overall, patients reported positive perceptions, experiences, and satisfaction with the cancer services pharmacist counselling services during their oral antineoplastic treatment.
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Affiliation(s)
- Lorna McNabb
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
| | - Eva Metrot
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
| | - Micaela Ferrington
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
| | - Bruce Sunderland
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
| | - Richard Parsons
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
| | - Tandy-Sue Copeland
- Pharmacy Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia
| | - Siobhan Corscadden
- Pharmacy Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia
| | - Selina Tong
- Pharmacy Department, Fiona Stanley Hospital, Murdoch, Western Australia, Australia
| | - Petra Czarniak
- Curtin Medical School, Faculty of Health Sciences, Curtin University, Bentley, Western Australia, Australia
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Angus F, Wang Y, Rigg A, Chen LC. Investigating adherence to tyrosine kinase inhibitors in renal cancer. J Oncol Pharm Pract 2024:10781552241259354. [PMID: 38839571 DOI: 10.1177/10781552241259354] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/07/2024]
Abstract
INTRODUCTION Tyrosine kinase inhibitors (TKIs) have been used as the first-line treatment for many patients with renal cell carcinoma (RCC), the seventh most common cancer in the United Kingdom. However, suboptimal adherence to TKIs can result in poor clinical prognosis. This study quantified RCC patients' adherence to TKIs and explored factors associated with suboptimal adherence. METHOD This retrospective cohort study was conducted at a specialist oncology tertiary hospital in Northwest England, using pharmacy dispensing records between November 2021 and March 2022. TKI prescriptions dispensed to patients with RCC were extracted to calculate the persistency gaps (≥7 or ≥14 days) and medication possession ratio (MPR). Multilevel regression analysis was conducted to associate MPR and persistency gaps with specific patient-related and TKI-related factors. This study did not require ethics approval. RESULTS Of the 2225 prescriptions dispensed to 109 patients, 469 (23.4%) and 274 (13.7%) persistency gaps of ≥7 and ≥14 days were identified. About 75% and 92% of patients had a persistency gap of ≥7 days within the first 90 days and 180 days. The length of time since the first TKI prescription (p < 0.001) and the use of sunitinib(p = 0.003) were significantly associated with the number of prescription gaps of ≥7 days. Moreover, the median MPR was 95.6% (interquartile range: 90.7%, 100.1%). Similarly, the length of time since the first TKI prescription was dispensed (p < 0.001) and the use of sunitinib (p = 0.034) were significantly associated with MPR. DISCUSSION AND CONCLUSION This single-centre study found that patients with RCC generally adhere to TKIs (MPR > 90%), but many patients experienced a persistency gap. The crucial window to mitigate TKI utilisation is within 180 days after the initial dispensing of TKIs. Further large-scale studies are required to comprehensively investigate other factors associated with adherence to TKIs and develop interventions to improve adherence and medication use problems.
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Affiliation(s)
- Fiona Angus
- Pharmacy Department, Christie NHS Foundation Trust, Manchester, UK
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
| | - Yubo Wang
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
| | - Alexander Rigg
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
| | - Li-Chia Chen
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
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Ononogbu O, Akindele O, Yazdanfard S, Fatima B, Abughosh S, Trivedi MV. Immunomodulator adherence in multiple myeloma patients with lower socioeconomic status: a retrospective study. Support Care Cancer 2024; 32:407. [PMID: 38833106 DOI: 10.1007/s00520-024-08619-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2023] [Accepted: 05/29/2024] [Indexed: 06/06/2024]
Abstract
OBJECTIVE Poor adherence to oral chemotherapy adversely impacts clinical outcomes and escalates overall healthcare costs. Despite barriers to medication adherence, a significant gap remains in assessing adherence to oral chemotherapy among multiple myeloma (MM) patients with lower socioeconomic status. Hence, our study aims to evaluate immunomodulator adherence in MM patients at a county hospital, primarily serving underrepresented and indigent individuals with low socioeconomic status across the greater Houston area. METHODS Inclusion criteria composed of patients diagnosed with MM, aged at least 18 years, and treated with lenalidomide or pomalidomide-two widely used immunomodulators-for a minimum of 2 months or having two or more records of dispensation between May 2019 and May 2021. Adherence was gauged using an adjusted version of the medication possession ratio (MPR). RESULTS Sixty-two patients were enrolled, yielding a mean MPR value of 88% (SD, ± 18.9). Of these, 43 patients (69.3%) demonstrated adherence with an MPR of ≥ 0.90. A significant difference was found in treatment duration between the adherent (mean 8.8 months; SD, ± 7.2) and non-adherent (mean 13.4 months; SD, ± 7.9) groups (p = 0.027). Notably, race/ethnicity demonstrated a significant difference (p = 0.048), driven by disparities in African American and Hispanic representation across adherence levels. CONCLUSION In summary, our findings highlight race and treatment duration to be predictors of immunomodulator adherence among MM patients with lower socioeconomic status. Further research is imperative to devise and test innovative interventions aimed at enhancing medication adherence, thereby contributing to improved survival and healthcare quality in this population.
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Affiliation(s)
- Onyebuchi Ononogbu
- Department of Pharmacy Practice and Translational Research, College of Pharmacy, University of Houston, Houston, TX, USA.
| | | | - Sahar Yazdanfard
- Department of Pharmacy Practice and Translational Research, College of Pharmacy, University of Houston, Houston, TX, USA
- Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, TX, USA
| | - Bilqees Fatima
- Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, TX, USA
| | - Susan Abughosh
- Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, TX, USA
| | - Meghana V Trivedi
- Department of Pharmacy Practice and Translational Research, College of Pharmacy, University of Houston, Houston, TX, USA
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Dragvoll I, Bofin AM, Søiland H, Engstrøm MJ. How to Optimize Deimplementation of Sentinel Lymph Node Biopsy? Breast J 2024; 2024:7623194. [PMID: 39742356 PMCID: PMC11142862 DOI: 10.1155/2024/7623194] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2023] [Revised: 04/23/2024] [Accepted: 05/04/2024] [Indexed: 01/03/2025]
Abstract
Background The omission of sentinel lymph node biopsy in low-risk elderly breast cancer patients has been introduced in several guidelines. Despite evidence to support its safety, this recommendation has not been implemented by many clinicians. We have examined two aspects of this recommendation that may explain why sentinel lymph node biopsy continues to be performed in most of these patients. Firstly, we quantified the proportion of patients diagnosed with axillary metastases postoperatively. Secondly, we examined adherence to antihormonal therapy in the same group of patients. Methods In this single-centre retrospective cohort study, the study population comprised 98 patients with breast cancer. Patients were aged ≥70 years and diagnosed with hormone receptor positive breast cancers less than 20 mm (T1). All patients underwent surgery and were subsequently prescribed five years of adjuvant antihormonal treatment. Results Axillary lymph node metastases, as confirmed by the postoperative histology report, were seen in 36.3%. Nonadherence was seen in 33.7% of the patients. Primary nonadherence, that is, patients that never collect their first or subsequent prescriptions at the pharmacy, comprised 11.2% of the total study population. Conclusion The high proportion of axillary metastases demonstrated suggests that clinical examination of the axilla alone is not sufficient in the preoperative assessment of the axilla. The less-than-optimal adherence rates show that adherence in these patients cannot be taken for granted. We suggest that these factors reflect some of the reluctance among clinicians to omit the sentinel lymph node procedure in these patients.
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Affiliation(s)
- Ida Dragvoll
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim 7491, Norway
- Department of Breast and Endocrine Surgery, St. Olav's Hospital, Trondheim University Hospital, Pb 3250 Torgarden, Trondheim 7006, Norway
| | - Anna M. Bofin
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim 7491, Norway
| | - Håvard Søiland
- Department of Research, Stavanger University Hospital, Pb 8100, Stavanger 4068, Norway
- Department of Clinical Science, University of Bergen, Jonas Lies vei 87, Bergen 5021, Norway
| | - Monica Jernberg Engstrøm
- Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim 7491, Norway
- Department of Breast and Endocrine Surgery, St. Olav's Hospital, Trondheim University Hospital, Pb 3250 Torgarden, Trondheim 7006, Norway
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12
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Vyas A, Parikh MA, Campbell PJ, Green A, Westrich K, Kogut S. Association between adherence with oral anticancer medications and short-term health care resource utilization: A 2010-2018 claims-based analysis. J Manag Care Spec Pharm 2024; 30:326-335. [PMID: 38241280 PMCID: PMC10982576 DOI: 10.18553/jmcp.2024.23134] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/21/2024]
Abstract
BACKGROUND There is limited evidence on the effect of adherence to oral anticancer medications on health care resource utilization (HRU) among patients with cancer. OBJECTIVE To determine the association between adherence to oral anticancer medication and subsequent HRU. METHODS A retrospective cohort study was conducted using Optum Clinformatics® Data Mart commercial claims database. Patients who initiated an oral anticancer medication between 2010 and 2017 were included. Proportion of days covered was used to calculate medication adherence in the first 6 months after oral anticancer medication initiation. All-cause HRU in the following 6 months was assessed. Multivariable negative binomial regressions were used to determine the association between oral anticancer medication adherence and HRU, after controlling for confounders. RESULTS Of 37,938 patients, 51.9% were adherent to oral anticancer medications. Adherence with oral anticancer medication was significantly associated with more frequent physician office and outpatient visits for several cancer types with the strongest association among those with liver cancer (adjusted incidence rate ratio [aIRR] = 1.34; 95% CI = 1.18-1.52 and aIRR = 1.32; 95% CI = 1.13-1.55, respectively). Oral anticancer medication adherence was associated with more emergency department visits only among patients with lung cancer (aIRR = 1.22; 95% CI = 1.01-1.48). Oral anticancer medication adherence was significantly associated with a higher rate of inpatient hospitalizations and longer stays among patients with liver cancer (aIRRs were 1.45 [95% CI = 1.02-2.05] and 2.15 [95% CI = 1.21-3.81], respectively), whereas hospitalizations were fewer and length of stay was shorter among patients with colorectal cancer who were adherent with oral anticancer medication (aIRRs were 0.77 [95% CI = 0.68-0.86] and 0.77 [95% CI = -0.66 to 0.90], respectively). Other measures did not reveal statistically significant differences in HRU among adherent and nonadherent patients for the cancer types included in the study. CONCLUSIONS HRU following the initial phase of oral anticancer medication therapy was generally similar among adherent and nonadherent patients. We observed a slightly higher rate of office and outpatient visits among adherent patients, which may reflect ongoing monitoring among patients continuing oral anticancer medication. Further studies are needed to determine how oral anticancer medication adherence may affect HRU over a longer time period.
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Affiliation(s)
- Ami Vyas
- Department of Pharmacy Practice and Clinical Research, College of Pharmacy, University of Rhode Island, Kingston
| | | | | | | | | | - Stephen Kogut
- Department of Pharmacy Practice and Clinical Research, College of Pharmacy, University of Rhode Island, Kingston
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Nguyen A, Uppal S, Pereira MM, Pluti A, Gualtieri L. MedHerent: Improving Medication Adherence in Older Adults With Contextually Sensitive Alerts Through an Application That Adheres to You. MAYO CLINIC PROCEEDINGS. DIGITAL HEALTH 2024; 2:1-7. [PMID: 40206667 PMCID: PMC11975706 DOI: 10.1016/j.mcpdig.2023.11.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 04/11/2025]
Abstract
Medication adherence has long been viewed as a patient issue, but what if we shift this perspective? What if medications could adjust to the needs and context of patients, instead of the other way around? We used design thinking to create a contextually sensitive digital health mobile application to improve medication adherence in older adults. We define contextual sensitivity as sensitivity to the context of patient needs. Through persona and scenario ideation, interviews, evaluations of existing solutions, prototypes, and consultations with subject matter experts, we uncovered key barriers to medication adherence. We outline 4 key challenges: alert fatigue, poor health literacy, lack of social support, and lack of behavior change and motivation, which are specific to older adults. The resulting application features reminders and alerts, a dashboard and calendar, educational resources, social sharing, and reward features. These 5 elements emphasize the significance of design thinking, contextual sensitivity, trimodal alerts, and co-interventions in developing effective digital health solutions for medication adherence among older adults.
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Kim JH, Lee Y, Kim DY, Kim S, Seo SS, Kang S, Park SY, Lim MC. Adherence of PARP inhibitor for frontline maintenance therapy in primary epithelial ovarian cancer: a cross-sectional survey. J Gynecol Oncol 2024; 35:e3. [PMID: 37681357 PMCID: PMC10792206 DOI: 10.3802/jgo.2024.35.e3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Revised: 05/22/2023] [Accepted: 08/13/2023] [Indexed: 09/09/2023] Open
Abstract
OBJECTIVE To identify the adherence rate to poly (ADP-ribose) polymerase (PARP) inhibitors and identify factors contributing to the deterioration of adherence at our institution. METHODS The adherence rate to PARP inhibitors was calculated using self-reported Adherence to Refills and Medications Scale questionnaires from a cross-sectional survey. Multivariable logistic regression analysis was performed to identify the factors that affected adherence. RESULTS Of the 131 respondents, 32 (24.4%) showed non-adherence to PARP inhibitors. In the multivariable logistic regression analysis, unemployed or retired status (odds ratio [OR]=4.878; 95% confidence interval [CI]=1.528-15.572; p=0.008), patients receiving niraparib (OR=3.387; 95% CI=1.283-8.940; p=0.014), and a lower score on the quality-of-life assessment (EORTC-QLQ-OV28), which reflects a better quality of life (QOC) with a lower symptom burden (OR=1.056; 95% CI=1.027-1.086; p<0.001) were associated with high adherence to PARP inhibitors. CONCLUSION Approximately one-fourth of patients with ovarian cancer are non-adherent to PARP inhibitors as maintenance treatment for newly diagnosed advanced ovarian cancer. The occupational status, type of PARP inhibitor, and QOC may affect adherence to PARP inhibitors.
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Affiliation(s)
- Ji Hyun Kim
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Yumi Lee
- Department of Nursing, Pukyong National University, Busan, Korea
| | - Da-Young Kim
- Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea
| | - Sinae Kim
- Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Korea
| | - Sang-Soo Seo
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Sokbom Kang
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Sang-Yoon Park
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
| | - Myong Cheol Lim
- Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea
- Rare & Pediatric Cancer Branch and Immuno-oncology Branch, Division of Rare and Refractory Cancer, Research Institute, National Cancer Center, Goyang, Korea
- Center for Clinical Trial, Hospital, National Cancer Center, Goyang, Korea.
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15
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Tateai Y, Kawakami K, Teramae M, Fukuda N, Yokokawa T, Kobayashi K, Shibata N, Suzuki W, Shimizu H, Takahashi S, Ozaka M, Sasahira N, Hori S, Yamaguchi M. Factors associated with lenvatinib adherence in thyroid cancer and hepatocellular carcinoma. PLoS One 2023; 18:e0294320. [PMID: 37972015 PMCID: PMC10653419 DOI: 10.1371/journal.pone.0294320] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2023] [Accepted: 10/30/2023] [Indexed: 11/19/2023] Open
Abstract
BACKGROUND Lenvatinib is an oral anticancer medication used to treat radioiodine-refractory thyroid cancer and unresectable hepatocellular carcinoma. The purpose of this study is to evaluate lenvatinib adherence by patients and to identify factors associated with decreased lenvatinib adherence. METHODS Among 153 patients who started treatment with lenvatinib for unresectable thyroid cancer or unresectable hepatocellular carcinoma between May 1, 2015 and August 31 2021 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 102 were eligible for this study (55 thyroid cancer, 47 hepatocellular carcinoma). The lenvatinib adherence rate in a treatment cycle was defined as the number of times a patient took lenvatinib in a 28-day cycle divided by the prescribed 28 doses. The rate was determined by pill counting and self-reporting at the pharmaceutical outpatient clinic. Reasons for non-adherence were established by interview and analyzed. RESULTS The median adherence rate of lenvatinib in the first cycle was 90.1% (n = 55) in thyroid cancer and 94.9% (n = 47) in hepatocellular carcinoma. In thyroid cancer, there were 255 incidents of lenvatinib non-adherence. Non-adherence was mainly associated with bleeding events (18.6%), followed by hand-foot skin reactions (10.6%). In hepatocellular carcinoma, there were 97 incidents of non-adherence. Hypertension accounted for 20.6%, followed by hoarseness (18.6%) and diarrhea (17.5%). CONCLUSION The adherence rate for lenvatinib in Japanese patients with thyroid and hepatocellular carcinoma in real-world clinical practice was more than 90% in this study. Hypertension was a major reason for non-adherence, followed by hand-foot skin reactions and diarrhea.
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Affiliation(s)
- Yoshikazu Tateai
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Kazuyoshi Kawakami
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Minori Teramae
- Division of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, Japan
| | - Naoki Fukuda
- Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Takashi Yokokawa
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Kazuo Kobayashi
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Naoki Shibata
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Wataru Suzuki
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Hisanori Shimizu
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Shunji Takahashi
- Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Masato Ozaka
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Naoki Sasahira
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Satoko Hori
- Division of Drug Informatics, Keio University Faculty of Pharmacy, Tokyo, Japan
| | - Masakazu Yamaguchi
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
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Dang TH, O'Callaghan C, Alexander M, Burbury K, Jayaraman PP, Wickramasinghe N, Schofield P. "Take the tablet or don't take the tablet?"-A qualitative study of patients' experiences of self-administering anti-cancer medications related to adherence and managing side effects. Support Care Cancer 2023; 31:680. [PMID: 37934298 PMCID: PMC10630231 DOI: 10.1007/s00520-023-08122-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2023] [Accepted: 10/16/2023] [Indexed: 11/08/2023]
Abstract
PURPOSE Medication non-adherence is a well-recognised problem in cancer care, negatively impacting health outcomes and healthcare resources. Patient-related factors influencing medication adherence (MA) are complicated and interrelated. There is a need for qualitative research to better understand their underlying interaction processes and patients' needs to facilitate the development of effective patient-tailored complex interventions. This study aimed to explore experiences, perceptions, and needs relating to MA and side effect management of patients who are self-administering anti-cancer treatment. METHODS Semi-structured audio-recorded interviews with patients who have haematological cancer were conducted. A comparative, iterative, and predominantly inductive thematic analysis approach was employed. RESULTS Twenty-five patients from a specialist cancer hospital were interviewed. While self-administering cancer medications at home, patients' motivation to adhere was affected by cancer-related physical reactions, fears, cancer literacy and beliefs, and healthcare professional (HCP) and informal support. Patients desired need for regular follow-ups from respectful, encouraging, informative, responsive, and consistent HCPs as part of routine care. Motivated patients can develop high adherence and side effect self-management over time, especially when being supported by HCPs and informal networks. CONCLUSION Patients with cancer need varied support to medically adhere to and manage side effects at home. HCPs should adapt their practices to meet the patients' expectations to further support them during treatment. We propose a multi-dimensional and technology- and theory-based intervention, which incorporates regular HCP consultations providing tailored education and support to facilitate and maintain patient MA and side effect self-management.
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Affiliation(s)
- Thu Ha Dang
- Department of Psychological Sciences, School of Health Sciences, Swinburne University of Technology, Melbourne, VIC, Australia.
- Department of Health Services Research and Implementation Science, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
- Digital Health Cooperative Research Centre, Sydney, Australia.
| | - Clare O'Callaghan
- Caritas Christi and Psychosocial Cancer Care, St Vincent's Hospital, Melbourne, VIC, Australia
- Department of Medicine, St Vincent's Hospital, The University of Melbourne, Melbourne, VIC, Australia
| | - Marliese Alexander
- Pharmacy Department, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
- Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia
| | - Kate Burbury
- Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia
- Digital and Healthcare Innovation, Peter McCallum Cancer Centre, Melbourne, VIC, Australia
| | - Prem Prakash Jayaraman
- Factory of the Future and Digital Innovation Lab, School of Science, Computing and Engineering Technologies, Swinburne University of Technology, Melbourne, VIC, Australia
| | - Nilmini Wickramasinghe
- Optus Digital Health, La Trobe University, Melbourne, VIC, Australia
- Department of Health and Bio Statistics, School of Health Sciences and Iverson Health Innovation Research Institute, Swinburne University of Technology, Melbourne, VIC, Australia
- Epworth Healthcare, Victoria, Australia
| | - Penelope Schofield
- Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia
- Department of Psychological Sciences and Iverson Health Innovation Research Institute, Swinburne University of Technology, Melbourne, VIC, Australia
- Digital Cancer Care Innovation, Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia
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Kibbons AM, Moore R, Choi L, Zuckerman AD. Patient-Tailored Interventions to Improve Specialty Medication Adherence: Results from a Prospective Randomized Controlled Trial. Am J Med 2023; 136:694-701.e1. [PMID: 37028694 PMCID: PMC10794990 DOI: 10.1016/j.amjmed.2023.03.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2023] [Revised: 03/01/2023] [Accepted: 03/16/2023] [Indexed: 04/09/2023]
Abstract
BACKGROUND Specialty medication nonadherence results in poor clinical outcomes and increased costs. This study evaluated the impact of patient-tailored interventions on specialty medication adherence. METHODS A pragmatic, randomized controlled trial was conducted at a single-center health-system specialty pharmacy from May 2019 to August 2021. Participants included recently nonadherent patients prescribed self-administered specialty medications from multiple specialty clinics. Eligible patients were stratified by historical clinic rates of nonadherence and randomized 1:1 to usual care or intervention arms. Intervention patients received patient-tailored interventions and 8 months of follow-up. A Wilcoxon test was used to analyze the difference in 6-, 8-, and 12-month post-enrollment adherence, calculated using proportion of days covered, between the intervention and usual care arms. RESULTS Four hundred and thirty eight patients were randomized. Baseline characteristics were similar between groups: mostly women (68%), white (82%), with a median age of 54 years (interquartile range, 40, 64). The most common reasons for nonadherence in the intervention arm were memory (37%) and unreachability (28%). There was a significant difference in median proportion of days covered between patients in the usual care and intervention arms at 8-months (0.88 vs 0.94, P < .001), 6-months (0.90 vs 0.95, P = .003), and 12-months post-enrollment (0.87 vs 0.93, P < .001). CONCLUSIONS Patient-tailored interventions resulted in significant specialty medication adherence improvement compared with standard of care. Specialty pharmacies should consider targeting nonadherent patients for adherence interventions.
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Affiliation(s)
| | - Ryan Moore
- Vanderbilt University Medical Center, Nashville, United States
| | - Leena Choi
- Vanderbilt University Medical Center, Nashville, United States
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18
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Delmas A, Batchelder L, Arora I, Bayet S, Bruhn D, Eberhardt A, Philpott S, Rodriguez-Leboeuf AM. Exploring preferences of different modes of administration of hypomethylating agent treatments among patients with acute myeloid leukemia. Front Oncol 2023; 13:1160966. [PMID: 37223688 PMCID: PMC10202170 DOI: 10.3389/fonc.2023.1160966] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2023] [Accepted: 04/11/2023] [Indexed: 05/25/2023] Open
Abstract
Introduction About half of patients with Acute Myeloid Leukemia (AML) are not eligible for Standard Induction Chemotherapy (SIC). Hypomethylating Agents (HMAs) intravenously (IV) or subcutaneously (SC) in a clinical setting are typically offered as an alternative. However, injectable HMAs may be burdensome for patients given the frequent hospital visits and side effects. This study explored patient treatment preferences for different modes of administration (MOA) and the relative importance of treatment-related characteristics that influence treatment decisions. Methods Semi-structured 1:1 interviews were conducted with 21 adult patients with AML in Germany, the United Kingdom, and Spain, who are not eligible for SIC, had experience with HMAs or were scheduled to be treated with HMAs. After discussing their experience of living with AML and its treatments, patients were presented with hypothetical treatment scenarios to explore their preferences, and a ranking exercise to assess the relative importance of treatment characteristics that influence their treatment-decisions for AML. Results Most patients reported an overall preference for oral administration over parenteral routes (71%), mostly due to convenience. Those preferring IV or SC routes (24%) reasoned with faster speed of action and onsite monitoring. When presented with a hypothetical situation of a patient having to choose between two AML treatments that were identical except for their MOA, the majority preferred the oral route (76%). Regarding treatment characteristics that influence treatment decisions, patients most frequently reported efficacy (86%) and side effects (62%) as important, followed by mode of administration (29%), daily life impacts (24%) and location of treatment (hospital versus home) (14%). However, only efficacy and side effects were rated as number one deciding factors (67% and 19%, respectively). Patients most frequently rated dosing regimen (33%) as least important. Conclusion The insights gained from this study may help support patients with AML who are receiving HMA treatment instead of SIC. A potential oral HMA with similar efficacy and tolerability profiles to injectable HMAs could influence treatment decisions. Furthermore, an oral HMA treatment might decrease the burden of parenteral therapies and improve patients' overall quality of life. However, the extent of influence MOA has on treatment decisions requires further investigation.
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Affiliation(s)
- Audrey Delmas
- Otsuka Pharmaceutical Europe Ltd., Wexham, United Kingdom
| | | | | | | | - David Bruhn
- Otsuka Pharmaceutical Development & Commercialization Inc., Rockville, MD, United States
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Abstract
INTRODUCTION Telepharmacy has the potential to enhance pharmacy services in oncology care, especially in remote areas. This scoping review explored the range, critical benefits and barriers of using telepharmacy services in oncology care. METHODS The scoping review followed the Arksey and O'Malley's five-stage framework to identify available evidence. PubMed, CINAHL, Embase, PsycINFO, Ovid MEDLINE and Scopus databases were searched for original research published between 2010 and 2020. The five dimensions of the Alberta Quality Matrix for Health were used to analyse reported outcomes. RESULTS Eligible articles (n = 21) were analysed. Telepharmacy in oncology care was used for follow-up, monitoring and counselling, intravenous chemotherapy and sterile compounding, expanding availability of pharmacy services, and remote education. Telepharmacy obtained high acceptability among cancer patients (n = 5) and healthcare professionals (n = 5), and increased accessibility of pharmaceutical services to underserved cancer populations (n = 2). Commonly cited effectiveness and safety outcomes were improved patient adherence (n = 5), increased pharmacy services (n = 3) and early identification of medication-related problems (n = 5). Telepharmacy improved efficiency in staffing and workload (n = 3), and increased cost savings (n = 3). A shortage of resources (n = 5), technical problems (n = 4) and prolonged turnaround time (n = 4), safety concerns (n = 2) and patient willingness to pay (n = 1) were identified barriers to implementing telepharmacy in oncology care. DISCUSSION Despite evidence pointing to the advantages and opportunities for expanding oncology pharmacy services through telepharmacy, certain challenges remain. Further research is needed to investigate safety concerns and patient willingness to pay for telepharmacy services.
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Affiliation(s)
- Anh Thu Vo
- Faculty of Medicine, Memorial University of Newfoundland, Canada
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Fleshner NE, Alibhai SMH, Connelly KA, Martins I, Eigl BJ, Lukka H, Aprikian A. Adherence to oral hormonal therapy in advanced prostate cancer: a scoping review. Ther Adv Med Oncol 2023; 15:17588359231152845. [PMID: 37007631 PMCID: PMC10064469 DOI: 10.1177/17588359231152845] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2022] [Accepted: 01/09/2023] [Indexed: 03/31/2023] Open
Abstract
Background Orally administrated agents play a key role in the management of prostate cancer, providing a convenient and cost-effective treatment option for patients. However, they are also associated with adherence issues which can compromise therapeutic outcomes. This scoping review identifies and summarizes data on adherence to oral hormonal therapy in advanced prostate cancer and discusses associated factors and strategies for improving adherence. Methods PubMed (inception to 27 January 2022) and conference databases (2020-2021) were searched to identify English language reports of real-world and clinical trial data on adherence to oral hormonal therapy in prostate cancer using the key search terms 'prostate cancer' AND 'adherence' AND 'oral therapy' OR respective aliases. Results Most adherence outcome data were based on the use of androgen receptor pathway inhibitors in metastatic castration-resistant prostate cancer (mCRPC). Self-reported and observer-reported adherence data were used. The most common observer-reported measure, medication possession ratio, showed that the vast majority of patients were in possession of their medication, although proportion of days covered and persistence rates were considerably lower, raising the question whether patients were consistently receiving their treatment. Study follow-up for adherence was generally around 6 months up to 1 year. Studies also indicate that persistence may drop further with longer follow-up, especially in the non-mCRPC setting, which may be a concern when years of therapy are required. Conclusions Oral hormonal therapy plays an important role in the treatment of advanced prostate cancer. Data on adherence to oral hormonal therapies in prostate cancer were generally of low quality, with high heterogeneity and inconsistent reporting across studies. Short study follow-up for adherence and focus on medication possession rates may further limit relevance of available data, especially in settings that require long-term treatment. Additional research is required to comprehensively assess adherence.
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Affiliation(s)
- Neil E. Fleshner
- Princess Margaret Cancer Centre, University of Toronto, 610 University Ave, Toronto, ON M5G 2M9, Canada
| | | | - Kim A. Connelly
- Keenan Research Centre for Biomedical Science, St. Michael’s Hospital, Toronto, ON, Canada
| | | | - Bernhard J. Eigl
- BC Cancer Vancouver, University of British Columbia, Vancouver, BC, Canada
| | - Himu Lukka
- Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada
| | - Armen Aprikian
- McGill University Health Centre, McGill University, Montreal, QC, Canada
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Rescigno P, Maruzzo M, Rebuzzi SE, Murianni V, Cinausero M, Lipari H, Fratino L, Gamba T, De Giorgi U, Caffo O, Bimbatti D, Dri A, Mosca A, Giunta EF, Ermacora P, Vignani F, Msaki A, Bonifacio B, Lombardo V, Conteduca V, Basso U, Fornarini G, Banna GL. Adherence to Oral Treatments in Older Patients with Advanced Prostate Cancer, the ADHERE Study: A Prospective Trial of the Meet-URO Network. Oncologist 2022; 27:e949-e956. [PMID: 35920559 PMCID: PMC9732238 DOI: 10.1093/oncolo/oyac147] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2022] [Accepted: 06/24/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Novel androgen receptor signaling inhibitors for prostate cancer (PC) impose the burden of self-administration on older patients overwhelmed by the requirement of many other concomitant medications. PATIENTS AND METHODS This study evaluated the proportion of non-adherence in a 12-month follow-up period and the first 3 months to abiraterone (ABI) or enzalutamide (ENZ). In a prospective multicenter observational cohort study, patients with metastatic castration-resistant PC (mCRPC) aged ≥70 years receiving ABI or ENZ pre- or post-docetaxel were enrolled. Treatment monitoring included pill counting, a self-assessment questionnaire, and clinical diaries at each clinical visit. Non-adherence rates were based on proportions of missed/prescribed pills ratios by pill counting. RESULTS Overall, 234 patients were recruited with median age of 78 years (range, 73-82); 86 (37%) were treated with ABI, and 148 (63%) with ENZ. The median follow-up for adherence was seven monthly cycles (IQR: 4-12). The two cohorts were well balanced for baseline characteristics. The percentage of non-adherence by pill counting was slightly higher for ABI than ENZ (5.2% vs. 4.2%, P < .001). By self-reporting, patients on ENZ tended to report more frequently than those with ABI forgetfulness as the reason for missing events (42% vs. 17%, P < .001). A lower Geriatric G8 score correlated with non-adherence (P = .004). Overall survival (OS) was 48.8 months. Patients on ABI had radiographic progression-free survival (rPFS) of 28.4 [24.2-32.5], while for ENZ patients, we reported a median rPFS of 23.1 [18.2-28.1] months. CONCLUSION Physicians tend to treat older mCRPC patients with ENZ. Non-adherence rate is relatively low overall but can be higher with ABI than with ENZ and correlates with the Geriatric G8 score. Forgetfulness is a potential barrier for ENZ.
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Affiliation(s)
| | - Marco Maruzzo
- Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy
| | - Sara Elena Rebuzzi
- Medical Oncology Unit, Ospedale San Paolo, Savona, Italy.,Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genova, Genova, Italy
| | - Veronica Murianni
- Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova, Italy
| | - Marika Cinausero
- Department of Oncology, ASUFC Santa Maria Della Misericordia, Udine, Italy
| | - Helga Lipari
- Division of Medical Oncology, Cannizzaro Hospital, Catania, Italy
| | - Lucia Fratino
- Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano CRO-IRCCS, Aviano, Italy
| | - Teresa Gamba
- Medical Oncology, Mauriziano Hospital,Turin, Italy
| | - Ugo De Giorgi
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
| | - Orazio Caffo
- Department of Medical Oncology, Santa Chiara Hospital, Trento, Italy
| | - Davide Bimbatti
- Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy
| | - Arianna Dri
- Department of Oncology, ASUFC Santa Maria Della Misericordia, Udine, Italy.,Department of Medicine, University of Udine, Udine, Italy
| | | | | | - Paola Ermacora
- Department of Oncology, ASUFC Santa Maria Della Misericordia, Udine, Italy
| | | | - Aichi Msaki
- Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy
| | - Barbara Bonifacio
- Department of Oncology, ASUFC Santa Maria Della Misericordia, Udine, Italy
| | | | - Vincenza Conteduca
- Department of Medical and Surgical Sciences, Unit of Medical Oncology and Biomolecular Therapy, University of Foggia, Policlinico Riuniti, Foggia, Italy
| | - Umberto Basso
- Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy
| | - Giuseppe Fornarini
- Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova, Italy
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22
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Pagliuca M, Donato M, D’Amato AL, Rosanova M, Russo AOM, Scafetta R, De Angelis C, Trivedi MV, André F, Arpino G, Del Mastro L, De Laurentiis M, Puglisi F, Giuliano M. New steps on an old path: Novel estrogen receptor inhibitors in breast cancer. Crit Rev Oncol Hematol 2022; 180:103861. [DOI: 10.1016/j.critrevonc.2022.103861] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2022] [Revised: 10/25/2022] [Accepted: 10/25/2022] [Indexed: 11/11/2022] Open
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Doshi SD, Lichtenstein MRL, Beauchemin MP, Raghunathan R, Lee S, Law C, Accordino MK, Elkin EB, Wright JD, Hershman DL. Factors Associated With Patients Not Receiving Oral Anticancer Drugs. JAMA Netw Open 2022; 5:e2236380. [PMID: 36227596 PMCID: PMC9561978 DOI: 10.1001/jamanetworkopen.2022.36380] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
IMPORTANCE Oral anticancer drugs (OACDs) are increasingly prescribed for cancer treatment and require significant coordination of care. Retrospective studies suggest that 10% to 20% of OACD prescriptions are never received by the patients, but the reasons behind this are poorly understood. OBJECTIVES To estimate the rate of failure to receive OACD prescriptions among patients with cancer and to examine the underlying reasons for this failure. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study was conducted among patients with cancer who were prescribed a new OACD from January 1, 2018, to December 31, 2019, at an urban academic medical center. Data analysis was conducted between 2021 and 2022. MAIN OUTCOMES AND MEASURES Patient demographic, clinical, and insurance data and OACD delivery dates were collected. The reasons for a failure to receive a prescribed OACD within 3 months were confirmed by manual review of medical records and were classified into 7 categories: clinical deterioration, financial access, clinician-directed change in decision-making, patient-directed change in decision-making, transfer of care, loss to follow-up, and unknown or other. A multivariable random-effects model was developed to identify factors associated with failure to receive a prescribed OACD. RESULTS The cohort included 1024 patients (538 men [53%]; mean [SD] age, 66.2 [13.9] years; 463 non-Hispanic White patients [45%], 140 non-Hispanic Black patients [14%], and 300 Hispanic patients [29%]), representing 1197 new OACD prescriptions. Of the 1197 prescriptions, 158 (13%) were categorized as having not been received by the patient. The most common reason for the failure to receive a prescribed OACD was due to patient and clinician decision-making (73 of 158 [46%]), and 20 cases (13%) in which prescriptions were not received were associated with financial access issues. In multivariable analysis, patients with a nonmetastatic solid malignant neoplasm were significantly less likely to not receive their OACDs than those with a hematologic malignant neoplasm (odds ratio, 0.57 [95% CI, 0.33-1.00]; P = .048). CONCLUSIONS AND RELEVANCE This cohort study of patients prescribed a new OACD found that 13% of prescriptions were not received. The failure to receive a prescribed OACD was most frequently due to a change in clinical decision-making or patient choice. Ultimately, the reasons for the failure to receive a prescribed OACD were multifactorial and may have been appropriate in some cases.
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Affiliation(s)
- Sahil D. Doshi
- Division of Medical Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Morgan R. L. Lichtenstein
- Divison of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
| | - Melissa P. Beauchemin
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
- School of Nursing, Columbia University Irving Medical Center, New York, New York
| | - Rohit Raghunathan
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
| | - Shing Lee
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
| | - Cynthia Law
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
| | - Melissa K. Accordino
- Divison of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
| | - Elena B. Elkin
- Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York
| | - Jason D. Wright
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York
| | - Dawn L. Hershman
- Divison of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
- Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, New York
- Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York
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24
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Bright EE, Genung SR, Stanton AL, Arch JJ. A mixed-methods study of the technical feasibility and patient acceptability of a real-time adherence monitor in breast cancer survivors taking adjuvant endocrine therapy. Breast Cancer Res Treat 2022; 195:393-399. [PMID: 35962148 PMCID: PMC9901531 DOI: 10.1007/s10549-022-06705-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2022] [Accepted: 08/01/2022] [Indexed: 11/29/2022]
Abstract
PURPOSE Oral anti-cancer medications are increasingly common and endocrine therapies represent the most common oral anti-cancer medications in breast cancer. Adjuvant endocrine therapies reduce the likelihood of recurrence and mortality in the approximately 80% of women diagnosed with hormone-receptor-positive breast cancer, thus rendering adherence essential. Real-time medication adherence monitors, such as the Wisepill electronic pillbox, transmit adherence data remotely, allowing for early intervention for non-adherence. However, their feasibility and acceptability have yet to be examined among breast cancer survivors taking endocrine therapies. METHODS This study presents quantitative patient-report and technical support data and qualitative patient acceptability data on Wisepill, a common real-time adherence monitor, among 88 breast cancer survivors prescribed adjuvant endocrine therapy. RESULTS This mixed-methods study of a common real-time adherence monitor, among the first in breast cancer survivors taking adjuvant endocrine therapy, demonstrates its technical feasibility and patient acceptability. CONCLUSION The use of wireless medication monitors that transmit real-time adherence data is uniquely promising for maximizing the benefits of adjuvant endocrine therapy by allowing for continuous tracking, ongoing communication with oncologic or research teams, and early intervention. This study demonstrates the feasibility and patient acceptability of one such real-time adherence monitor.
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Affiliation(s)
- Emma E Bright
- Department of Psychology and Neuroscience, University of Colorado, Box 345, Boulder, CO, 80309-0345, USA.
| | - Sarah R Genung
- Department of Psychology and Neuroscience, University of Colorado, Box 345, Boulder, CO, 80309-0345, USA
| | - Annette L Stanton
- Department of Psychology, University of California, Los Angeles, CA, USA
- Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, USA
- Cousins Center for Psychoneuroimmunology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA
| | - Joanna J Arch
- Department of Psychology and Neuroscience, University of Colorado, Box 345, Boulder, CO, 80309-0345, USA
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25
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Dinan MA, Wilson LE, Greiner MA, Spees LP, Pritchard JE, Zhang T, Kaye D, George D, Scales CD, Baggett CD, Gross CP, Leapman MS, Wheeler SB. Oral Anticancer Agent (OAA) Adherence and Survival in Elderly Patients With Metastatic Renal Cell Carcinoma (mRCC). Urology 2022; 168:129-136. [PMID: 35878815 PMCID: PMC9588695 DOI: 10.1016/j.urology.2022.07.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2022] [Revised: 06/27/2022] [Accepted: 07/10/2022] [Indexed: 11/17/2022]
Abstract
OBJECTIVE To examine real-world adherence to oral anticancer agents (OAAs) and its association with outcomes among Medicare beneficiaries with metastatic renal cell carcinoma (mRCC). METHODS SEER-Medicare retrospective cohort study of patients with metastatic renal cell carcinoma (mRCC) who received an OAA between 2007 and 2015. We examined A) adherence and B) overall and disease-specific 2-year survival landmarked at 3 months after OAA initiation. Adherence was assessed by calculating the proportion of days covered (PDC) within 3 months of OAA initiation, with adherent use being defined as PDC > 80%. RESULTS A total of 905 patients met study criteria, of whom 445 patients (49.2%) were categorized as adherent to initial OAA treatment. Adjusting for clinical and demographic factors revealed decreased odds of adherence associated with living within an impoverished neighborhood (OR 0.49, CI 0.0.33 - 0.74) and out-of-pocket costs > $200 (OR 0.68, CI 0.47-.98). Adherence was associated with improved 2-year survival in univariate analysis (logrank test, P = .01) and a non-significant trend toward an association with decreased all-cause (HR 0.87, CI 0.72 - 1.05) and RCC-specific survival (HR 0.84, CI 0.69 - 1.03) in multivariable analysis. CONCLUSION Local poverty levels and high out-of-pocket costs are associated with poor initial adherence to OAA therapy in Medicare beneficiaries with mRCC, which in turn, suggests a trend toward poor overall and disease-specific survival. Efforts to improve outcomes in the broader mRCC population should incorporate OAA adherence and economic factors.
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Affiliation(s)
- Michaela A Dinan
- Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT; Yale Cancer Outcomes, Public Policy, and Effectiveness Research Center, New Haven, CT.
| | - Lauren E Wilson
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC
| | - Melissa A Greiner
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC
| | - Lisa P Spees
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC; Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC
| | - Jessica E Pritchard
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC
| | - Tian Zhang
- Duke Cancer Institute, Durham, NC; Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC
| | - Deborah Kaye
- Department of Surgery (Urology), Duke University School of Medicine, Durham, NC
| | - Daniel George
- Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC
| | - Charles D Scales
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC; Department of Surgery (Urology), Duke University School of Medicine, Durham, NC
| | - Chris D Baggett
- Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC; Department of Epidemiology, Gillings School of Global Public Health, UNC-CH, Chapel Hill, NC
| | - Cary P Gross
- Yale Cancer Outcomes, Public Policy, and Effectiveness Research Center, New Haven, CT; Department of Medicine, Yale School of Medicine, New Haven, CT
| | - Michael S Leapman
- Yale Cancer Outcomes, Public Policy, and Effectiveness Research Center, New Haven, CT; Department of Urology, Yale School of Medicine, New Haven, CT
| | - Stephanie B Wheeler
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC; Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC
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Signorelli J, Bell C, Monaco S. Oral oncolytic monitoring pilot with patient-reported outcomes and adherence assessments. J Oncol Pharm Pract 2022:10781552221112603. [PMID: 36113036 DOI: 10.1177/10781552221112603] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/18/2024]
Abstract
INTRODUCTION Patients on oral oncolytics are responsible for self-monitoring adherence and adverse drug reactions (ADRs). Oncology pharmacists are in position to focus on quality and safety of care for patients on oncolytics while providing communication between the patient, physician, and specialty pharmacies. This pilot aimed to monitor patients treated by our leukemia team initiated on oral oncolytics. METHODS From July 2020 to February 2021, patients treated by our leukemia team newly started on oncolytics were included. Pharmacists performed medication reconciliation and drug interaction screening on initiation of oral oncolytic. Pharmacists followed up at predefined intervals. On follow up adherence was assessed using the Morisky Medication Adherence Scale-8 (MMAS-8) and patient reported outcomes (PROs) were assessed using the revised Edmonton Symptom Assessment Scale (ESAS-r). After each follow-up, a note was placed in the chart with assessment scores and recommendations. RESULTS A total of 32 patients were screened with 19 patients included. Oral oncolytics included: imatinib (4), dasatinib (5), ponatinib (1), gilteritinib (2), enasidenib (1), and venetoclax (6). Fourteen drug interactions were identified, 11 medications discontinued, nine medications added, and two medications doses were changed. Twenty-six adherence assessments were performed with 21, 4, and 1 assessment demonstrating adherence, medium adherence, and low adherence, respectively. 62 ESAS-r assessments were performed with 64% reported as no symptoms, 17% as mild, 13% as moderate, and 5% as severe symptoms. Twenty laboratory tests were ordered from pharmacist recommendation on initiation and follow-up. CONCLUSION This pilot demonstrated the role pharmacists play in oral oncolytic monitoring and symptom management.
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Affiliation(s)
- Jessie Signorelli
- Department of Pharmacy, 2348Massachusetts General Hospital, Boston, MA, USA
| | - Christopher Bell
- Department of Pharmacy, 2348Massachusetts General Hospital, Boston, MA, USA
| | - Stephanie Monaco
- Department of Pharmacy, 5803Memorial Sloan Kettering Cancer Center, New York City, NY, USA
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Reed P, Osborne LA, Whittall CM, Emery S, Truzoli R. Patient and economic benefits of psychological support for noncompliant patients. Front Psychol 2022; 13:829880. [PMID: 36186372 PMCID: PMC9521354 DOI: 10.3389/fpsyg.2022.829880] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2021] [Accepted: 07/25/2022] [Indexed: 12/03/2022] Open
Abstract
The current paper provides an overview of treatment noncompliance at various points in the treatment pathway, especially with respect to treatment for Pelvic-floor Dysfunction (PFD). The effects of noncompliance on healthcare are considered, and examples of supporting patients psychologically to increase compliance are discussed. An outline of a method to identify costs of non-compliance, and where such costs most intensely impact the healthcare system, is provided. It is suggested that psychological support is effective in terms of increased compliance and improved healthcare economics. The model is presented for PFD, but the principles developed can be generalised to many aspects of healthcare.
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Affiliation(s)
- Phil Reed
- Department of Psychology, Swansea University, Swansea, United Kingdom
| | - Lisa A. Osborne
- School of Psychology and Counselling, The Open University, Milton Keynes, United Kingdom
- Swansea Bay University Health Board, Swansea, United Kingdom
| | | | - Simon Emery
- Swansea Bay University Health Board, Swansea, United Kingdom
| | - Roberto Truzoli
- Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy
- *Correspondence: Roberto Truzoli,
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Kirkegaard J, Lundholm BW, Rosenberg T, Lund T, Gundesen MT, Dieperink KB. Home is best. Self-administration of subcutaneous Bortezomib at home in patients with multiple myeloma - A mixed method study. Eur J Oncol Nurs 2022; 60:102199. [PMID: 36162259 DOI: 10.1016/j.ejon.2022.102199] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/27/2022] [Revised: 08/10/2022] [Accepted: 08/31/2022] [Indexed: 11/04/2022]
Abstract
OBJECTIVES To examine the perspectives of patients and healthcare professionals of self-administration of subcutaneous (SC) injection of Bortezomib in the homes of patients with Multiple Myeloma (MM), and to assess organizational aspects. METHODS A prospective, clinical, parallel mixed-method design with a qualitative core and a quantitative supplementary component was conducted at a single hematological centre in Denmark. Qualitative data were obtained from individual, semi-structured interviews with patients (n = 10) and a focus group interview with healthcare professionals (n = 5); data were analyzed using a hermeneutic approach. Quantitative data were acquired from time registrations performed by patients and nurses and descriptively analyzed applying a micro-costing approach, using cost data per individual. RESULTS In general, patients and healthcare professionals were pleased with self-administration as patient empowerment increased. Qualitative findings yielded three themes: "Home is best", "Everyone is different", and "Safety first". Quantitative data were confirmative and revealed self-administration to be time saving for patients and nurses. In a Danish context, delivery of the medicine to the patient's home was slightly more expensive than administration at the hospital. CONCLUSIONS Self-administration of SC Bortezomib in the homes of patients with MM is advantageous for patients and healthcare professionals. It is feasible, safe, and timesaving. These advantages come with a negligible increase in expenses.
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Affiliation(s)
- Jannie Kirkegaard
- Department of Hematology, Odense University Hospital, Kloevervaenget 10, 12th floor, 5000, Odense C, Denmark
| | - Birgitte Wolf Lundholm
- Department of Hematology, Odense University Hospital, Kloevervaenget 10, 12th floor, 5000, Odense C, Denmark
| | - Tine Rosenberg
- Department of Hematology, Odense University Hospital, Kloevervaenget 10, 12th floor, 5000, Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19.3, DK-5000, Odense C, Denmark.
| | - Thomas Lund
- Department of Hematology, Odense University Hospital, Kloevervaenget 10, 12th floor, 5000, Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19.3, DK-5000, Odense C, Denmark
| | - Michael Tveden Gundesen
- Department of Hematology, Odense University Hospital, Kloevervaenget 10, 12th floor, 5000, Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19.3, DK-5000, Odense C, Denmark
| | - Karin Brochstedt Dieperink
- Research Unit of Oncology, The Academy of Geriatric Cancer Research Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløws Vej 19.3, DK-5000, Odense C, Denmark; Family Focused Healthcare Research Center (FaCe), University of Southern Denmark, J.B. Winsløws Vej 19.3, DK-5000, Odense C, Denmark
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Porcher L, Perron V, Blanc J, Kaderbhai CG, Tharin Z, Schmitt A, Gallet M. Smartphone-based application and nurses' interventions for symptoms monitoring in patients treated with oral anticancer agents: A 1-year follow-up in a tertiary cancer center. J Oncol Pharm Pract 2022:10781552221117731. [PMID: 35938191 DOI: 10.1177/10781552221117731] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
AIM The increasing use of oral anticancer agents over the past years has necessitated changes in monitoring toxicities to ensure patients' adherence and tolerance at home. The aim of this study was to describe nurses' interventions and medical changes after alerts triggered by a web-based platform designed to support the management of oral anticancer agents-related toxicities. METHODS This retrospective study included patients undergoing oral anticancer agents in a cancer center from September 2018 to September 2019 (excluding hormonal therapy). In this cancer center, the standard of care included symptoms' collections for 1 month thanks to a web platform based on patient-reported outcomes. Patients had to fill a weekly questionnaire (Q1 to Q4). The web-based platform triggered orange alerts when patients reported moderate symptoms and red alerts when severe toxicities were declared. The rate of orange and red alerts, the rate of patients with medical changes consecutively to an orange or a red alert, and the different types of nurses' interventions and medical changes were assessed. RESULTS A total of 524 patients were extracted but the final number of 436 patients were included in this study and 1488 questionnaires were filled in. More than 90% of patients declared that they took their medication as prescribed. Up to 60% of patients recorded all grade symptoms, including 8% of patients who recorded Grades 3-4 symptoms during the month, mostly anorexia, fatigue, and diarrhea. The web platform system triggered 700 orange and 212 red alerts: 305/700 (44%) of orange alerts resulted in nurses' interventions, most frequently phone counseling (78%), and 65/212 (31%) of red alerts resulted in medical changes, most frequent treatment interruptions (48%). CONCLUSION Implementing an e-health (electronic-health) system can be helpful for monitoring symptoms in patients under oral anticancer agents, enhancing that this organization should be a standard of care in every cancer centers.
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Affiliation(s)
- Laura Porcher
- Pharmacy Department, 55482Centre Georges François Leclerc, Dijon, France
| | - Valérie Perron
- Day Hospital Department, 55482Centre Georges François Leclerc, Dijon, France
| | - Julie Blanc
- Statistic Department, 55482Centre Georges François Leclerc, Dijon, France
| | | | - Zoé Tharin
- Oncology Department, 55482Centre Georges François Leclerc, Dijon, France
| | - Antonin Schmitt
- Pharmacy Department, 55482Centre Georges François Leclerc, Dijon, France
- INSERM U1231, University of Burgundy Franche-Comté, Dijon, France
| | - Matthieu Gallet
- Pharmacy Department, 55482Centre Georges François Leclerc, Dijon, France
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Vyas A, Descoteaux A, Kogut S, Parikh MA, Campbell PJ, Green A, Westrich K. Predictors of adherence to oral anticancer medications: An analysis of 2010-2018 US nationwide claims. J Manag Care Spec Pharm 2022; 28:831-844. [PMID: 35876294 PMCID: PMC10372994 DOI: 10.18553/jmcp.2022.28.8.831] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
BACKGROUND: Various factors, including patient demographic and socioeconomic characteristics, patient out-of-pocket (OOP) costs, therapy-related factors, clinical characteristics, and health-system factors, can affect patient adherence to oral anticancer medications (OAMs). OBJECTIVE: To determine the proportion of patients initiating oral anticancer therapy who were adherent to OAMs and to identify significant predictors of adherence to OAMs, including patient OOP costs and patient demographics. METHODS: A retrospective cohort study was conducted using data from Optum Clinformatics Data Mart commercial claims database for 2010-2018. Patients with a new pharmacy claim for an OAM between July 1, 2010, and December 31, 2017, were followed for 6 months to ascertain their medication adherence, which was defined as a proportion of days covered value of at least 0.8. Average monthly patient OOP costs for OAM prescriptions were categorized as lower OOP costs (quartiles 1-3) and higher OOP costs (quartile 4). Separate multivariable logistic regressions were conducted to identify predictors of OAM nonadherence for each cancer type. RESULTS: Out of 37,938 patients with cancer, 51.9% were adherent to OAMs, with adherence ranging from 32.8% among those with liver cancer to 70.4% among those with brain tumor. The average monthly OOP costs of OAMs also differed by cancer type, ranging from $749 (SD = $1,014) among patients with blood cancer to $106 (SD = $439) among those with prostate cancer. Higher patient OOP costs were associated with higher odds of OAM nonadherence for many cancer types, including renal cancer (adjusted odds ratio [AOR] = 3.91; 95% CI = 2.80-5.47) and breast cancer (AOR = 1.26; 95% CI = 1.13-1.41). Additionally, patients with inpatient hospitalizations during the 6 months following OAM initiation had significantly higher odds of OAM nonadherence for all cancer types except for stomach cancer. Among patients with stomach cancer, male sex was associated with lower odds of OAM nonadherence (AOR = 0.60; 95% CI = 0.37-0.97). Among patients with renal or stomach cancer, those who had Medicare low-income subsidy had higher odds of OAM nonadherence compared with those with commercial insurance coverage. Among patients with blood cancers, Black and Hispanic patients had higher odds of OAM nonadherence compared with White patients (AOR = 1.48; 95% CI = 1.25-1.75 and AOR = 1.38; 95% CI = 1.13-1.68, respectively). CONCLUSIONS: Overall adherence to OAMs was suboptimal, and for several cancer types, adherence was worse among patients with higher OOP costs, those who were hospitalized, and those who received Medicare low-income subsidy. Policies addressing cost and access to OAMs and health-system strategies to address barriers to the effective use of OAMs are needed to improve patient access to these vital medications. DISCLOSURES: This study was funded by joint funding from the Pharmacy Quality Alliance and the National Pharmaceutical Council (NPC). Drs Vyas and Kogut were partially supported by this joint funding. Mr Descoteaux was supported by this joint funding for performing data analysis. The content is solely the responsibility of the authors and does not necessarily represent the official views of PQA or NPC. Dr Campbell completed this work during his employment at Pharmacy Quality Alliance; he is now an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ.
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Affiliation(s)
- Ami Vyas
- Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston
| | - Andrew Descoteaux
- Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston
| | - Stephen Kogut
- Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston
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Liu W, Han Y, Xin X, Chen L, Liu Y, Liu C, Zhang X, Jin M, Jin J, Gao Z, Huang W. Biomimetic and temporal-controlled nanocarriers with ileum transporter targeting for achieving oral administration of chemotherapeutic drugs. J Nanobiotechnology 2022; 20:281. [PMID: 35705976 PMCID: PMC9199201 DOI: 10.1186/s12951-022-01460-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2022] [Accepted: 05/11/2022] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND Oral chemotherapy is preferred for patients with cancer owing to its multiple advantages, including convenience, better patient compliance, and improved safety. Nevertheless, various physical barriers exist in this route that hamper the development of oral chemotherapeutic formulations, including destruction of drugs in the gastrointestinal tract (GIT), low permeability in enterocytes, and short residence time in the intestine. To overcome these limitations, it is necessary to design an efficient oral drug delivery system with high efficacy and improved safety. RESULTS Herein, we designed novel glycocholic acid (GCA)-functionalized double layer nanoparticles (GCA-NPs), which can act via an endogenous pathway and in a temporally controlled manner in the intestine, to enhance the oral bioavailability of hydrophobic chemotherapeutic drugs such as paclitaxel (PTX). GCA-NPs were composed of quercetin (Qu)-modified liposomes (QL) coated with GCA-chitosan oligosaccharide conjugate (GCOS). The GCA-NPs thus prepared showed prolonged intestinal retention time and good GIT stability due to the presence of chitosan oligosaccharide (COS) and enhanced active transportation via intestinal apical sodium-dependent bile acid transporter (ASBT) due to the presence of GCA. GCA-NPs also efficiently inhibited intestinal P-gp induced by Qu. PTX-loaded GCA-NPs (PTX@GCA-NPs) had a particle size of 84 nm and an entrapment efficiency of 98% with good stability. As a result, the oral bioavailability of PTX was increased 19-fold compared to that of oral Taxol® at the same dose. Oral PTX@GCA-NPs displayed superior antitumor efficacy and better safety than Taxol® when administered intravenously. CONCLUSIONS Our novel drug delivery system showed remarkable efficacy in overcoming multiple limitations and is a promising carrier for oral delivery of multiple drugs, which addresses several challenges in oral delivery in the clinical context.
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Affiliation(s)
- Wei Liu
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Ying Han
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Xin Xin
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Liqing Chen
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Yanhong Liu
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Chao Liu
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Xintong Zhang
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Mingji Jin
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Jingzhe Jin
- Department of Oncology, The First Hospital of Dandong City, Dandong, Liaoning 118000 People’s Republic of China
| | - Zhonggao Gao
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
| | - Wei Huang
- grid.506261.60000 0001 0706 7839State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China ,grid.506261.60000 0001 0706 7839Beijing Key Laboratory of Drug Delivery Technology and Novel Formulations, Department of Pharmaceutics, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050 People’s Republic of China
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Kaye DR, Wilson LE, Greiner MA, Spees LP, Pritchard JE, Zhang T, Pollack CE, George D, Scales CD, Baggett CD, Gross CP, Leapman MS, Wheeler SB, Dinan MA. Patient, provider, and hospital factors associated with oral anti-neoplastic agent initiation and adherence in older patients with metastatic renal cell carcinoma. J Geriatr Oncol 2022; 13:614-623. [PMID: 35125336 PMCID: PMC9232903 DOI: 10.1016/j.jgo.2022.01.008] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2021] [Revised: 12/16/2021] [Accepted: 01/13/2022] [Indexed: 12/27/2022]
Abstract
INTRODUCTION Oral anti-neoplastic agents (OAAs) for metastatic renal cell carcinoma (mRCC) are associated with increased cancer-specific survival. However, racial disparities in survival persist and older adults have the lowest rates of cancer-specific survival. Research from other cancers demonstrates specialty access is associated with high-quality cancer care, but older adults receive cancer treatment less often than younger adults. We therefore examined whether patient, provider, and hospital characteristics were associated with OAA initiation, adherence, and cancer-specific survival after initiation and whether race, ethnicity, and/or age was associated with an increased likelihood of seeing a medical oncologist for diagnosis of mRCC. PATIENTS AND METHODS We used Surveillance, Epidemiology, and End Results (SEER)Medicare data to identify patients ≥65 years of age who were diagnosed with mRCC from 2007 to 2015 and enrolled in Medicare Part D. Insurance claims were used to identify receipt of OAAs within twelve months of metastatic diagnosis, calculate proportion of days covered, and to identify the primary cancer provider and hospital. We examined provider and hospital characteristics associated with OAA initiation, adherence, and all-cause mortality after OAA initiation. RESULTS We identified 2792 patients who met inclusion criteria. Increased OAA initiation was associated with access to a medical oncologist. Patients were less likely to begin OAA treatment if their primary oncologic provider was a urologist (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.77). Provider/hospital characteristics were not associated with differences in OAA adherence or mortality. Patients who started sorafenib (odds ratio [OR] 0.50; 95% CI 0.29-0.86), were older (aged >81 OR 0.56; 95% CI 0.34-0.92), and those living in high poverty ZIP codes (OR 0.48; 95% CI 0.29-0.80) were less likely to adhere to OAA treatment. Furthermore, provider characteristics did not account for differences in mortality once an OAA was initiated. Last, only age > 81 years was statistically and clinically associated with a decreased relative risk of seeing a medical oncologist (risk ratio [RR] 0.87; CI 0.82-0.92). CONCLUSION Provider/hospital factors, specifically, being seen by a medical oncologist for mRCC diagnosis, are associated with OAA initiation. Older patients were less likely to see a medical oncologist; however, race and/or ethnicity was not associated with differences in seeing a medical oncologist. Patient factors are more critical to OAA adherence and mortality after OAA initiation than provider/hospital factors.
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Affiliation(s)
- Deborah R Kaye
- Department of Surgery (Urology), Duke University School of Medicine, Durham, NC, United States of America; Duke-Margolis Policy Center, Duke University School of Medicine, Durham, NC, United States of America; Duke Cancer Institute, Durham, NC, United States of America
| | - Lauren E Wilson
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America
| | - Melissa A Greiner
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America
| | - Lisa P Spees
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC, United States of America; Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC, United States of America
| | - Jessica E Pritchard
- Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America
| | - Tian Zhang
- Duke Cancer Institute, Durham, NC, United States of America; Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America
| | - Craig E Pollack
- Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America
| | - Daniel George
- Duke Cancer Institute, Durham, NC, United States of America; Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America
| | - Charles D Scales
- Department of Surgery (Urology), Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America
| | - Chris D Baggett
- Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC, United States of America; Department of Epidemiology, Gillings School of Global Public Health, UNC-CH, Chapel Hill, NC, United States of America
| | - Cary P Gross
- Department of Medicine, Yale School of Medicine, New Haven, CT, United States of America; Yale Cancer Outcomes, Public Policy, and Effectiveness Research Center, New Haven, CT, United States of America
| | - Michael S Leapman
- Yale Cancer Outcomes, Public Policy, and Effectiveness Research Center, New Haven, CT, United States of America; Department of Urology, Yale School of Medicine, New Haven, CT, United States of America
| | - Stephanie B Wheeler
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, NC, United States of America; Lineberger Comprehensive Cancer Center, UNC-CH, Chapel Hill, NC, United States of America
| | - Michaela A Dinan
- Department of Urology, Yale School of Medicine, New Haven, CT, United States of America.
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Gori S, Modena A, Foglietta J, Verzè M, Inno A, Casarin A, Russo A, Nicolis F. Adherence to oral hormonal anticancer agents in breast cancer. TUMORI JOURNAL 2022:3008916221096183. [PMID: 35603579 DOI: 10.1177/03008916221096183] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
There is an increasing trend towards using oral antitumoral agents in oncological patients. Compared to parenteral therapy, oral treatment offers convenience for both the patient and the healthcare system, with similar efficacy. However, the benefit deriving from oral drugs will be obtained only if patients adhere strictly to the treatment. Medical oncologists must therefore seek to optimize patient adherence. Breast cancer patients, particularly, are often treated with oral hormonal anticancer agents. In this review, we summarized evidence about adherence of breast cancer patients to oral hormonal anticancer agents and the consequences of poor compliance, the barriers to oral treatment and strategies to overcome them.
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Affiliation(s)
- Stefania Gori
- Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
| | - Alessandra Modena
- Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
| | | | - Matteo Verzè
- Health Direction, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
| | - Alessandro Inno
- Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
| | - Alessandra Casarin
- Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
| | - Antonio Russo
- Department of Surgical, Oncological & Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy
| | - Fabrizio Nicolis
- Health Direction, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy
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34
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Rossi AA, Marconi M, Taccini F, Verusio C, Mannarini S. Screening for Distress in Oncological Patients: The Revised Version of the Psychological Distress Inventory (PDI-R). Front Psychol 2022; 13:859478. [PMID: 35602698 PMCID: PMC9121122 DOI: 10.3389/fpsyg.2022.859478] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2022] [Accepted: 03/17/2022] [Indexed: 12/17/2022] Open
Abstract
Background Psychological research in oncological settings is steadily increasing and the construct of psychological distress has rapidly gained popularity-leading to the development of questionnaires aimed at its measurement. The Psychological Distress Inventory (PDI) is one of the most used instruments, but its psychometric properties were not yet deeply evaluated. The present studies aimed at investigating the psychometric properties of the PDI (Study 1) and providing a revised version of the tool (Study 2). Methods Oncological outpatients were enrolled at the Department of Medical Oncology of the Presidio Ospedaliero of Saronno, ASST Valle Olona, Italy. For the first study (N = 251), an Exploratory Graph Analysis was used to explore the item structure of the PDI. In the second study (N = 902), the psychometric properties of the revised PDI (PDI-R) were deeply assessed. Results Study 1 showed that the PDI has a not clear structure and it should be reconsidered. On the opposite, Study 2 showed that the revised version (PDI-R) has a solid factorial structure, it is invariant across gender and age, and it has good psychometric properties. Conclusion Results suggest that the PDI-R is a reliable measure of psychological distress in different samples of oncological patients, with stronger psychometric properties than the original version. Its use in the clinical and research field is therefore recommended to improve the quality of both assessment and treatment of psychological distress in patients with oncological problems.
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Affiliation(s)
- Alessandro Alberto Rossi
- Section of Applied Psychology, Department of Philosophy, Sociology, Education, and Applied Psychology, University of Padova, Padua, Italy
- Interdepartmental Center for Family Research, University of Padova, Padua, Italy
| | - Maria Marconi
- Department of Medical Oncology, Presidio Ospedaliero di Saronno, ASST Valle Olona, Saronno, Italy
| | - Federica Taccini
- Interdepartmental Center for Family Research, University of Padova, Padua, Italy
| | - Claudio Verusio
- Department of Medical Oncology, Presidio Ospedaliero di Saronno, ASST Valle Olona, Saronno, Italy
| | - Stefania Mannarini
- Section of Applied Psychology, Department of Philosophy, Sociology, Education, and Applied Psychology, University of Padova, Padua, Italy
- Interdepartmental Center for Family Research, University of Padova, Padua, Italy
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35
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Verougstraete N, Stove V, Verstraete AG, Stove CP. Therapeutic Drug Monitoring of Tyrosine Kinase Inhibitors Using Dried Blood Microsamples. Front Oncol 2022; 12:821807. [PMID: 35392223 PMCID: PMC8980857 DOI: 10.3389/fonc.2022.821807] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Accepted: 03/01/2022] [Indexed: 12/14/2022] Open
Abstract
Therapeutic drug monitoring (TDM) of tyrosine kinase inhibitors (TKIs) is not yet performed routinely in the standard care of oncology patients, although it offers a high potential to improve treatment outcome and minimize toxicity. TKIs are perfect candidates for TDM as they show a relatively small therapeutic window, a wide inter-patient variability in pharmacokinetics and a correlation between drug concentration and effect. Moreover, most of the available TKIs are susceptible to various drug-drug interactions and medication adherence can be checked by performing TDM. Plasma, obtained via traditional venous blood sampling, is the standard matrix for TDM of TKIs. However, the use of plasma poses some challenges related to sampling and stability. The use of dried blood microsamples can overcome these limitations. Collection of samples via finger-prick is minimally invasive and considered convenient and simple, enabling sampling by the patients themselves in their home-setting. The collection of small sample volumes is especially relevant for use in pediatric populations or in pharmacokinetic studies. Additionally, working with dried matrices improves compound stability, resulting in convenient and cost-effective transport and storage of the samples. In this review we focus on the different dried blood microsample-based methods that were used for the quantification of TKIs. Despite the many advantages associated with dried blood microsampling, quantitative analyses are also associated with some specific difficulties. Different methodological aspects of microsampling-based methods are discussed and applied to TDM of TKIs. We focus on sample preparation, analytics, internal standards, dilution of samples, external quality controls, dried blood spot specific validation parameters, stability and blood-to-plasma conversion methods. The various impacts of deviating hematocrit values on quantitative results are discussed in a separate section as this is a key issue and undoubtedly the most widely discussed issue in the analysis of dried blood microsamples. Lastly, the applicability and feasibility of performing TDM using microsamples in a real-life home-sampling context is discussed.
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Affiliation(s)
- Nick Verougstraete
- Laboratory of Toxicology, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium.,Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium
| | - Veronique Stove
- Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium.,Department of Diagnostic Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - Alain G Verstraete
- Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium.,Department of Diagnostic Sciences, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
| | - Christophe P Stove
- Laboratory of Toxicology, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium
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Yanez B, Oswald LB, Van Denburg AN, Baik SH, Czech KA, Buitrago D, Maletich C, Wortman K, Penedo FJ, Victorson DE. Rationale and usability findings of an e-health intervention to improve oral anticancer adherence among breast cancer survivors: The My Journey mindfulness study. Contemp Clin Trials Commun 2022; 26:100898. [PMID: 35252622 PMCID: PMC8889091 DOI: 10.1016/j.conctc.2022.100898] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2021] [Revised: 01/04/2022] [Accepted: 01/29/2022] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND Approximately 80% of breast cancer survivors are prescribed oral endocrine therapy (ET) medication for 5-10 years following primary treatment, making adherence to ET a critical aspect of cancer survivorship care. Despite the benefits of ET, non-adherence is problematic, and up to half of breast cancer survivors ave been documented to discontinue ET early. Our team developed My Journey, an online, mindfulness-based program designed to improve adherence to ET. This manuscript describes the usability testing of My Journey and the protocol development for the My Journey randomized feasibility trial. METHODS Usability participants were women (N = 15) with a diagnosis of hormone receptor-positive non-metastatic breast cancer who had initiated ET. Participant impressions and feedback were collected qualitatively and quantitatively using items on usefulness, satisfaction, and ease of use. Participants in the 8-week feasibility trial (N = 80) will be randomized to receive the web-based My Journey intervention or a health education comparison condition. RESULTS Quantitative feedback on the usability trial was favorable, with a mean overall usability score of 106.3 (SD = 7.7; Range: 83-115) indicating above average usability. Qualitative data showed that participants found several strengths in the initial design of the My Journey online tool and that participants liked the layout of My Journey. CONCLUSIONS Findings indicate that the My Journey online tool is useable. The program's feasibility is being evaluated in a randomized trial.
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Affiliation(s)
- Betina Yanez
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Laura B. Oswald
- Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL, USA
| | | | | | | | - Diana Buitrago
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Carly Maletich
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Katy Wortman
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Frank J. Penedo
- University of Miami, Miller School of Medicine and Sylvester Cancer Center, Miami, FL, USA
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Levit LA, Arora S, Kluetz PG, Magnuson A, Rahman A, Harvey RD. Call to Action for Improving Oral Anticancer Agent Adherence. J Clin Oncol 2022; 40:1036-1040. [PMID: 34990218 DOI: 10.1200/jco.21.02529] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022] Open
Affiliation(s)
- Laura A Levit
- American Society of Clinical Oncology, Alexandria, VA
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Nizet P, Touchefeu Y, Pecout S, Cauchin E, Beaudouin E, Mayol S, Fronteau C, Huon JF. Exploring the factors influencing adherence to oral anticancer drugs in patients with digestive cancer: a qualitative study. Support Care Cancer 2022; 30:2591-2604. [PMID: 34812952 PMCID: PMC8794904 DOI: 10.1007/s00520-021-06663-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2021] [Accepted: 10/27/2021] [Indexed: 11/26/2022]
Abstract
PURPOSE The aim of this study was to explore the beliefs, perceptions and representations of patients in order to identify the determinants of oral anticancer drugs adherence and to take action in current practice to improve patient support in digestive oncology. METHODS We constructed a semi-directed interview guide which aimed to explore the patient's relationship with medication, their health history, their experiences at the time of the announcement of treatment, their confidence, their fears, their motivations to adhere to their treatment and the constraints linked to their treatment. The data were analysed and discussed using a thematic approach. RESULTS Seventeen patients agreed to participate in the study. The median age was 60 years. Ten patients had colorectal cancer, 3 patients had hepatocellular carcinoma, 3 patients had gastrointestinal stromal tumour and 1 patient had neuroendocrine pancreatic tumour. We identified five categories of factors influencing adherence: demographic and socioeconomic, disease-related, treatment-related, care system-related, and patient representation and pathways' factors. A majority of patients emphasised the importance of family support in the adherence process and the convenience of per os treatment compared to other intravenous treatments. However, several negative determinants emerged such as the toxicity of the treatment, fears of forgetting to take the medication, difficulties with the galenic formulation and negative beliefs of the family. CONCLUSION This study demonstrates the need to address the different dimensions of the patient in order to understand his or her behaviour with regard to adherence and to identify the levers for improvement.
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Affiliation(s)
- Pierre Nizet
- Clinical Pharmacy Unit, Nantes University Hospital, 1 Rue Gaston Veil, 44000, Nantes, France.
| | - Yann Touchefeu
- Digestive Oncology, Institut Des Maladies De L'Appareil Digestif, Nantes University Hospital, Nantes, France
| | - Solange Pecout
- Digestive Oncology, Institut Des Maladies De L'Appareil Digestif, Nantes University Hospital, Nantes, France
| | - Estelle Cauchin
- Digestive Oncology, Institut Des Maladies De L'Appareil Digestif, Nantes University Hospital, Nantes, France
| | - Eva Beaudouin
- INSERM, UMR 1246-SPHERE, MethodS in Patients-Centered Outcomes and HEalth ResEarch, Nantes and Tours, France
| | - Séverine Mayol
- Research Department, Nantes University Hospital, Nantes, France
| | - Clémentine Fronteau
- Clinical Pharmacy Unit, Nantes University Hospital, 1 Rue Gaston Veil, 44000, Nantes, France
| | - Jean-François Huon
- Clinical Pharmacy Unit, Nantes University Hospital, 1 Rue Gaston Veil, 44000, Nantes, France
- INSERM, UMR 1246-SPHERE, MethodS in Patients-Centered Outcomes and HEalth ResEarch, Nantes and Tours, France
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Heiss BL, Geynisman DM, Martinez E, Wong AS, Yong WP, Szmulewitz RZ, Stadler WM. Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial. Support Care Cancer 2022; 30:2803-2810. [PMID: 34845502 PMCID: PMC8830594 DOI: 10.1007/s00520-021-06670-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2021] [Accepted: 11/01/2021] [Indexed: 11/24/2022]
Abstract
PURPOSE Abiraterone acetate, prescribed for metastatic prostate cancer, has enhanced absorption with food. This effect was exploited in a randomized trial which showed noninferiority of PSA decline for 250 mg abiraterone with a low-fat meal (LOW) compared to 1,000 mg abiraterone fasting (STD). Drug was obtained via patient insurance. Patient out-of-pocket costs and adherence were surveyed. METHODS Trial participants were randomized to STD or LOW, and surveys of adherence and out-of-pocket costs were administered at baseline and just before coming off study (follow-up). RESULTS Out-of-pocket costs were available from 20 of 36 STD and 21 of 36 LOW patients. Median out-of-pocket costs for a month of drug were $0 (LOW) and $5 (STD); mean costs were $43.61 (LOW) and $393.83 (STD). The two groups did not differ significantly (p = 0.421). Maximum out-of-pocket cost was $1,000 (LOW) and $4,000 (STD). Monthly out-of-pocket costs > $500 were found in 1 LOW and 5 STD patients. For adherence, only 11 STD and 19 LOW patients had questionnaires completed at both baseline and follow-up. STD adherence was 98.18% at baseline and 91.69% at follow-up, differing significantly (p = 0.0078). LOW adherence was 96.52% at baseline and 97.86% at follow-up, not differing significantly (p = 0.3511). Adherence did not correlate with demographics. At follow-up, increasing adherence correlated significantly with decreasing dose (p = 0.013; rho = - 0.458). CONCLUSIONS Out-of-pocket costs did not differ significantly in this limited analysis. Adherence was significantly different in STD as the trial progressed, which was not found in LOW. TRIAL REGISTRATION ClinicalTrials.gov NCT01543776; registered March 5, 2012.
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Affiliation(s)
- Brian L. Heiss
- Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA,CORRESPONDING AUTHOR: Brian L. Heiss, Department of Medicine, Section of Hematology/Oncology, The University of Chicago, 5841 S. Maryland Ave, MC 2115, Chicago, IL 60637, 773-702-8653,
| | - Daniel M. Geynisman
- Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA
| | - Elia Martinez
- Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA
| | - Alvin S.C. Wong
- Department of Haematology-Oncology, National University Cancer Institute, Singapore
| | - Wei Peng Yong
- Department of Haematology-Oncology, National University Cancer Institute, Singapore
| | - Russell Z. Szmulewitz
- Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA
| | - Walter M. Stadler
- Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA
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Murphy M, Bennett K, Ryan S, Hughes CM, Lavan AH, Cadogan CA. A systematic scoping review of interventions to optimise medication prescribing and adherence in older adults with cancer. Res Social Adm Pharm 2022; 18:2392-2402. [PMID: 33903064 DOI: 10.1016/j.sapharm.2021.04.011] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2020] [Revised: 04/12/2021] [Accepted: 04/12/2021] [Indexed: 01/12/2023]
Abstract
BACKGROUND Older adults with cancer often require multiple medications (polypharmacy) comprising cancer-specific treatments, supportive care medications (e.g. analgesics), and medications for pre-existing health conditions. Increasing numbers of medications may increase risks of potentially inappropriate prescribing and non-adherence. OBJECTIVE To provide an overview of evaluations of interventions aimed at optimising medication prescribing and/or adherence in older adults with cancer. METHODS A systematic scoping review was undertaken. Four databases (PubMed, EMBASE, CINAHL, PsycINFO) were searched using relevant search terms (e.g. cancer, older adults). Eligible studies evaluated interventions seeking to improve medication prescribing and/or adherence in older adults (≥65 years) with cancer using a comparative evaluation. All outcomes for studies that met inclusion criteria were included in the review. Extracted data were collated using tables and accompanying narrative descriptive summaries. The review was reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. RESULTS Nine studies met inclusion criteria comprising five randomised controlled trials (RCTs) and four before-and-after study designs. Studies were primarily conducted in oncology clinics, ranging from single study sites to 109 oncology clinics. Sample sizes ranged between 33 and 4844 patients. Interventions most commonly involved patient education (n = 6) delivered by pharmacists or nurses. Three studies reported on prescribing-related outcomes and seven studies reported on adherence-related outcomes, using different terminology and assessment methods. Prescribing-related outcomes focused on medication appropriateness (using Beers criteria) and drug-related problems including drug interactions. Adherence-related outcomes included assessments of self-reported medication adherence and calculation of patients' medication possession ratio. CONCLUSIONS This scoping review highlights a lack of robust evaluations of interventions aimed at optimising medication prescribing and adherence in older adults with cancer. Future research should improve rigour during intervention development, evaluation and reporting in order to generate findings that could inform future practice.
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Affiliation(s)
- Melanie Murphy
- School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland
| | - Kathleen Bennett
- Population Health Sciences Division, Royal College of Surgeons in Ireland, Dublin, Ireland; Data Science Centre, Royal College of Surgeons in Ireland, Dublin, Ireland
| | - Sinéad Ryan
- School of Medicine, National University of Ireland, Galway, Ireland
| | - Carmel M Hughes
- School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom
| | - Amanda H Lavan
- Department of Medicine for the Elderly, St James's Hospital, Dublin, Ireland
| | - Cathal A Cadogan
- School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
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Passardi A, Foca F, Caffo O, Tondini CA, Zambelli A, Vespignani R, Bartolini G, Sullo FG, Andreis D, Dianti M, Eccher C, Piras EM, Forti S. A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial. J Med Internet Res 2022; 24:e27349. [PMID: 35080505 PMCID: PMC8829690 DOI: 10.2196/27349] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2021] [Revised: 06/10/2021] [Accepted: 11/10/2021] [Indexed: 11/13/2022] Open
Abstract
Background A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient–health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. Objective The overall aims of the trial are to customize the platform; assess the system’s ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. Methods Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. Results A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. Conclusions ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. Trial Registration ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724
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Affiliation(s)
- Alessandro Passardi
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Flavia Foca
- Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Orazio Caffo
- Department of Medical Oncology, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
| | - Carlo Alberto Tondini
- Department of Medical Oncology, Azienda Socio-Sanitaria Territoriale "Papa Giovanni XXIII", Bergamo, Italy
| | - Alberto Zambelli
- Department of Medical Oncology, Azienda Socio-Sanitaria Territoriale "Papa Giovanni XXIII", Bergamo, Italy
| | - Roberto Vespignani
- IT Service, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Giulia Bartolini
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Francesco Giulio Sullo
- Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Daniele Andreis
- Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy
| | - Marco Dianti
- Center for Information and Communication Technology, eHealth Unit, Fondazione "Bruno Kessler", Trento, Italy
| | - Claudio Eccher
- Center for Information and Communication Technology, eHealth Unit, Fondazione "Bruno Kessler", Trento, Italy
| | - Enrico Maria Piras
- Center for Information and Communication Technology, eHealth Unit, Fondazione "Bruno Kessler", Trento, Italy
| | - Stefano Forti
- Center for Information and Communication Technology, eHealth Unit, Fondazione "Bruno Kessler", Trento, Italy
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Oke O, Niu J, Chavez-MacGregor M, Zhao H, Giordano SH. Adjuvant tamoxifen adherence in men with early-stage breast cancer. Cancer 2022; 128:59-64. [PMID: 34597415 PMCID: PMC11927788 DOI: 10.1002/cncr.33899] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2021] [Revised: 06/02/2021] [Accepted: 06/07/2021] [Indexed: 01/04/2023]
Abstract
BACKGROUND Most breast cancers (BCs) in men are hormone receptor-positive. Adjuvant tamoxifen is part of the standard treatment of these patients. Small, single-institution studies have suggested that men have high rates of discontinuing adjuvant endocrine treatment. The authors examined rates of tamoxifen discontinuation and medication adherence in a large population-based cohort of male patients with BC. METHODS In the Surveillance, Epidemiology, and End Results-Medicare database, male patients with invasive nonmetastatic BC, diagnosed between 2007 and 2013, who were ≥65 years old, had Part D coverage, and had tamoxifen prescriptions within 1 year of diagnosis were identified. Adherence was defined as a medication possession ratio of ≥80% among those patients who were filling tamoxifen prescriptions. Logistic regression model was used to assess predictors of tamoxifen adherence. RESULTS A total of 451 patients met eligibility criteria. The median age at diagnosis was 75 years. The median follow-up was 32.5 months. The rates of tamoxifen discontinuation were 15.8%, 24.3%, 31.3%, 36.9%, and 48.3% at 1, 2, 3, 4, and 5 years after diagnosis, respectively. Among the men who were still taking tamoxifen, the corresponding adherence rates were 76.9%, 73.6%, 68.7%, 64.8%, and 60.2%. In the adjusted model, significant predictors of lower adherence included residing in a high poverty area (odds ratio [OR], 0.77; 95% confidence interval [CI], 0.28-2.12) and a Charlson comorbidity score of ≥2 (OR, 0.46; 95% CI, 0.22-0.97). CONCLUSION Older men with breast cancer have high rates of tamoxifen discontinuation, with 48% of all patients discontinuing tamoxifen before the end of year 5. Additionally, even among those patients continuing tamoxifen, a substantial number of patients are nonadherent. Further research should evaluate potentially modifiable reasons for treatment discontinuation and lack of adherence to tamoxifen.
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Affiliation(s)
- Oluchi Oke
- Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
- Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Jiangong Niu
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Mariana Chavez-MacGregor
- Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Hui Zhao
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Sharon H Giordano
- Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
- Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas
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Arend RC, O’Malley DM, Banerjee S, McLaurin K, Davidson R, Long GH. Utilization of Poly(ADP-Ribose) Polymerase Inhibitors in Ovarian Cancer: A Retrospective Cohort Study of US Healthcare Claims Data. Adv Ther 2022; 39:328-345. [PMID: 34727316 PMCID: PMC8799547 DOI: 10.1007/s12325-021-01959-5] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Accepted: 10/08/2021] [Indexed: 01/02/2023]
Abstract
Introduction We aimed to characterize real-world utilization of poly(ADP-ribose) polymerase (PARP) inhibitors (PARPi) in women with ovarian cancer (OC). Methods This retrospective observational study of claims data from US MarketScan® Commercial/Medicare Supplemental databases included women with OC initiating olaparib, niraparib, or rucaparib from January 1, 2017, to May 31, 2019. Patients were observed from first outpatient prescription until at least 30 days’ follow-up. Clinical events of interest (CEIs), based on adverse reactions in PARPi prescribing information, were identified from claims using ICD-9/10 codes. Other outcomes included dose modification, persistence, adherence, healthcare resource utilization (HCRU), and cost. Results Overall, 303, 348, and 162 women with OC received olaparib, niraparib, and rucaparib, respectively. During follow-up, risk of any CEI was higher with niraparib versus olaparib (odds ratio 3.36 [95% confidence interval 2.00–5.65]) and niraparib versus rucaparib (2.09 [1.10–3.95]), with no significant difference between rucaparib and olaparib (1.61 [0.93–2.79]). PARPi dose decreases were observed in 21.1%, 35.1%, and 30.2% of olaparib-, niraparib-, and rucaparib-treated patients, respectively. Persistence (no treatment gaps of more than 90 days) was significantly higher (P < 0.05) with olaparib (62.2%) versus niraparib (35.9%) and rucaparib (48.7%); adherence (medication possession ratio, MPR ≥ 80%) was 80.2% versus 38.6% and 63.2%, respectively (P < 0.001). Inpatient admissions and outpatient service use were higher with niraparib and rucaparib versus olaparib, reflected in mean (± standard deviation) total medical costs (excluding pharmacy) of $5393 ± 8828 for olaparib, $7732 ± 14,054 for niraparib, and $6868 ± 7929 for rucaparib. Conclusion Differences between the licensed PARPi were observed in the risk of experiencing a CEI, likelihood of dose modifications, ability to receive continuous PARPi therapy, HCRU, and costs. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01959-5.
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Psihogios AM, Rabbi M, Ahmed A, McKelvey ER, Li Y, Laurenceau JP, Hunger SP, Fleisher L, Pai AL, Schwartz LA, Murphy SA, Barakat LP. Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment. JMIR Res Protoc 2021; 10:e32789. [PMID: 34677129 PMCID: PMC8571686 DOI: 10.2196/32789] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/10/2021] [Accepted: 08/16/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake. OBJECTIVE This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion. METHODS At the Children's Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)-a version of an open-source app that was modified for AYAs with cancer through a user-centered process-and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion. RESULTS With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60% (18/30) have been enrolled; of the 18 enrolled, 15 (83%) have completed the study so far. CONCLUSIONS This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/32789.
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Affiliation(s)
- Alexandra M Psihogios
- Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
| | - Mashfiqui Rabbi
- Department of Statistics, Harvard University, Boston, MA, United States
| | - Annisa Ahmed
- Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA, United States
| | - Elise R McKelvey
- Children's Hospital of Philadelphia, La Salle University, Philadelphia, PA, United States
| | - Yimei Li
- Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
| | | | - Stephen P Hunger
- Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
| | - Linda Fleisher
- Health Communications and Health Disparities, Fox Chase Cancer Center, Philadelphia, PA, United States
| | - Ahna Lh Pai
- Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, United States
| | - Lisa A Schwartz
- Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
| | - Susan A Murphy
- Department of Statistics, Harvard University, Boston, MA, United States
| | - Lamia P Barakat
- Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
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Feral A, Boone M, Lucas V, Bihan C, Belhout M, Chauffert B, Lenglet A. Influence of the implementation of a multidisciplinary consultation program on adherence to the first ever course of oral antineoplastic treatment in patients with cancer. J Oncol Pharm Pract 2021; 28:1543-1551. [PMID: 34590521 DOI: 10.1177/10781552211035368] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
PURPOSE To evaluate adherence (as measured by the medication possession ratio) to the first ever course of oral antineoplasic treatment in cancer patients before and after the implementation of a multidisciplinary consultation program (involving an oncologist, a pharmacist, and a nurse) and to investigate the program's impact on adverse events and drug-related problems. PATIENTS AND METHODS In a retrospective single-center study, we compared the medication possession ratio 2 months after treatment initiation in a control group (before multidisciplinary consultation program implementation) versus an interventional group (after multidisciplinary consultation program implementation). RESULTS Two months after oral antineoplasic treatment initiation, the mean ± standard deviation medication possession ratio did not differ significantly when comparing the interventional (multidisciplinary consultation program) group (n = 33; 0.99 ± 0.06) with the control group (n = 64; 0.94 ± 0.16) (p = 0.062). Patients in the multidisciplinary consultation program group had fewer adverse events in general (41, vs 109 in the control group; p = 0.048) and digestive adverse events in particular (6 vs 29, respectively; p = 0.007). A total of 53 and 40 drug-related problems were identified in the control and multidisciplinary consultation program groups, respectively (p = 0.074). CONCLUSIONS Implementation of an multidisciplinary consultation program was not associated with a significant difference in drug adherence (as assessed by the medication possession ratio), which was good before and after implementation. The multidisciplinary consultation program was associated with a lower incidence of adverse events.
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Affiliation(s)
- Aurelie Feral
- Department of Clinical Pharmacy, 36673Amiens Picardie University Medical Center, France
| | - Mathieu Boone
- Department of Medical Oncology, 36673Amiens Picardie University Medical Center, France
| | - Virginie Lucas
- Department of Medical Oncology, 36673Amiens Picardie University Medical Center, France
| | - Céline Bihan
- Department of Medical Oncology, 36673Amiens Picardie University Medical Center, France
| | - Mohamed Belhout
- Department of Clinical Pharmacy, 36673Amiens Picardie University Medical Center, France
| | - Bruno Chauffert
- Department of Medical Oncology, 36673Amiens Picardie University Medical Center, France
| | - Aurelie Lenglet
- Department of Medical Oncology, 36673Amiens Picardie University Medical Center, France.,MP3CV Laboratory, EA7517, Faculty of Pharmacy, Jules Verne University of Picardie, France
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Moss HA, Chen L, Hershman DL, Davidson B, Wright JD. Adherence to PARP inhibitor therapy among women with ovarian cancer. Gynecol Oncol 2021; 163:262-268. [PMID: 34509297 DOI: 10.1016/j.ygyno.2021.08.025] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2021] [Revised: 08/23/2021] [Accepted: 08/25/2021] [Indexed: 11/18/2022]
Abstract
OBJECTIVE The objective of this study was to evaluate medical adherence for patients with ovarian cancer who initiated treatment with a PARP inhibitor therapy, and to identify factors associated with nonadherence. METHODS We used the MarketScan Database to identify ovarian cancer patients who initiated PARP inhibitor therapy between January 1, 2008 and December 31, 2017. The primary outcome was adherence defined as ≥ 80% proportion of days covered (PDC). A secondary outcome included adherence assessed using the medication possession ratio (MPR). Multivariable logistic regression analysis was performed to assess relation between PDC and explanatory variables. Sensitivity analysis was performed to evaluate impact of dose-adjustments and toxicity-related delays on adherence. RESULTS Among 170,976 patients diagnosed with ovarian cancer, 151 patients met inclusion criteria. The median time from diagnosis to initiating therapy was 33 months. Overall, 40 (26.5%) were non-adherent based on a PDC less than 80%. Non-adherent patients were more likely to receive niraparib and have a longer duration of therapy (p < 0.05). We found no significant impact of age, comorbidities, insurance plan, or year of PARP inhibitor initiation on non-adherence. In a sensitivity analysis to assess different definition of adherence, non-adherence ranged from 11.3% to 41.1%. When accounting for possible dose-adjustments, 21.2% of patients were non-adherent. CONCLUSION This population based study of ovarian cancer patients found that a quarter of patients may be sub-optimally adherent to PARP inhibitor therapy. Future research should focus on identification of patients at risk for nonadherence and interventions to lower nonadherence among these patients.
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Affiliation(s)
- Haley A Moss
- Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America.
| | - Ling Chen
- Columbia University Medical Center, New York, NY, United States of America
| | - Dawn L Hershman
- Columbia University Medical Center, New York, NY, United States of America
| | - Brittany Davidson
- Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States of America; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States of America
| | - Jason D Wright
- Columbia University Medical Center, New York, NY, United States of America; Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States of America; Herbert Irving Comprehensive Cancer Center, Columbia University College of Physicians and Surgeons, New York, NY, United States of America
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Spees LP, Wheeler SB, Jackson BE, Baggett CD, Wilson LE, Greiner MA, Kaye DR, Zhang T, George D, Scales CD, Pritchard JE, Leapman M, Gross CP, Dinan MA. Provider- and patient-level predictors of oral anticancer agent initiation and adherence in patients with metastatic renal cell carcinoma. Cancer Med 2021; 10:6653-6665. [PMID: 34480518 PMCID: PMC8495289 DOI: 10.1002/cam4.4201] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2021] [Revised: 07/28/2021] [Accepted: 07/29/2021] [Indexed: 01/25/2023] Open
Abstract
Background Improving oral anticancer agent (OAA) initiation and adherence is the important quality‐of‐care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider‐ and patient‐level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). Methods We used state cancer registry data linked to multi‐payer claims data to identify patients with mRCC diagnosed in 2004–2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. Results Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient‐level factors (RR = 1.37; 95% CL: 1.09–1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42–0.87). Conclusions Our results suggest that provider‐ and patient‐level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence.
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Affiliation(s)
- Lisa P Spees
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, North Carolina, USA.,Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, North Carolina, USA
| | - Stephanie B Wheeler
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (UNC-CH), Chapel Hill, North Carolina, USA.,Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, North Carolina, USA
| | - Bradford E Jackson
- Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, North Carolina, USA
| | - Christopher D Baggett
- Lineberger Comprehensive Cancer Center (LCCC), UNC-CH, Chapel Hill, North Carolina, USA.,Department of Epidemiology, Gillings School of Global Public Health, UNC-CH, Chapel Hill, North Carolina, USA
| | - Lauren E Wilson
- Department of Population Health Sciences, Duke University School of Medicine (DUSM), Durham, North Carolina, USA
| | - Melissa A Greiner
- Department of Population Health Sciences, Duke University School of Medicine (DUSM), Durham, North Carolina, USA
| | - Deborah R Kaye
- Duke Cancer Institute (DCI) Center for Prostate and Urologic Cancers, Durham, North Carolina, USA.,Department of Medicine, DUSM, Durham, North Carolina, USA
| | - Tian Zhang
- Duke Cancer Institute (DCI) Center for Prostate and Urologic Cancers, Durham, North Carolina, USA.,Department of Medicine, DUSM, Durham, North Carolina, USA.,Department of Surgery (Urology), DUSM, Durham, North Carolina, USA
| | - Daniel George
- Duke Cancer Institute (DCI) Center for Prostate and Urologic Cancers, Durham, North Carolina, USA.,Department of Medicine, DUSM, Durham, North Carolina, USA
| | - Charles D Scales
- Department of Population Health Sciences, Duke University School of Medicine (DUSM), Durham, North Carolina, USA.,Department of Surgery (Urology), DUSM, Durham, North Carolina, USA
| | - Jessica E Pritchard
- Department of Population Health Sciences, Duke University School of Medicine (DUSM), Durham, North Carolina, USA
| | - Michael Leapman
- Department of Urology, Yale School of Medicine, New Haven, Connecticut, USA.,Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, Connecticut, USA
| | - Cary P Gross
- Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, Connecticut, USA.,Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Michaela A Dinan
- Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, Connecticut, USA.,Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut, USA
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Poleon S, Racette L, Fifolt M, Schoenberger-Godwin YM, Abu SL, Twa MD. Patient and Provider Perspectives on Glaucoma Treatment Adherence: A Delphi Study in Urban Alabama. Optom Vis Sci 2021; 98:1085-1093. [PMID: 34524213 PMCID: PMC8505131 DOI: 10.1097/opx.0000000000001776] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Accepted: 04/30/2021] [Indexed: 11/26/2022] Open
Abstract
SIGNIFICANCE Patients with glaucoma and providers recognized perceived treatment efficacy, patient-provider relationship, psychological stress, instillation skill, good quality of life, and forgetfulness as key determinants of glaucoma adherence. This shared insight could help shape the development of clinical and behavioral interventions for addressing treatment barriers and improving adherence. PURPOSE Despite their impact on adherence in glaucoma, sociobehavioral factors may not be adequately explored during clinical consultations. We aimed to elicit consensus between patients and providers around key determinants of adherence and hypothesized that patients would place greater emphasis on sociobehavioral factors compared with providers. METHODS A two-round Delphi survey was used to assess treatment beliefs, barriers, facilitators, motivators, and needs among 18 patients with glaucoma and providers. In round 1, agreement with 46 statements was scored on a 5-point Likert scale (strongly disagree to strongly agree). Statements with which 80% or more of panelists agreed reached consensus and advanced to round 2, where participants were asked to prioritize them based on their importance to treatment. RESULTS There was consensus regarding the influence of perceived treatment efficacy, good provider relationship, good quality of life, psychological stress, glaucoma knowledge, instillation skill, and forgetfulness on glaucoma adherence. For statements that failed to reach consensus, the Bonferroni-corrected Mann-Whitney U test revealed that the greatest differences between patients and providers pertained to regimen complexity (provider median, 4 [interquartile range {IQR}, 1]; patient median, 1.5 [IQR, 1]; P = .002), instillation skill (providers, 4 [IQR, 0.5]; patients, 2 [IQR, 1]; P = .001), and low motivation (providers, 3 [IQR, 2.25]; patients, 1 [IQR, 0]; P = .003). CONCLUSIONS Although patients and providers prioritized sociobehavioral factors as key determinants of adherence, disagreement between these groups was observed in other areas. Continued juxtaposition of patient and provider perspectives could spotlight underexplored areas and guide the development of successful interventions for improving adherence.
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Affiliation(s)
- Shervonne Poleon
- Department of Optometry and Vision Science, University of Alabama at Birmingham School of Optometry, Birmingham, Alabama
| | - Lyne Racette
- Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama
| | - Matthew Fifolt
- Department of Health Care Organization and Policy, University of Alabama at Birmingham School of Public Health, Birmingham, Alabama
| | - Yu-Mei Schoenberger-Godwin
- Division of Preventive Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama
| | - Sampson Listowell Abu
- Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama
| | - Michael D. Twa
- University of Houston College of Optometry, Houston, Texas
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Ravandi F, Roboz GJ, Wei AH, Döhner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol 2021; 14:133. [PMID: 34454540 PMCID: PMC8401338 DOI: 10.1186/s13045-021-01142-x] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2021] [Accepted: 08/17/2021] [Indexed: 02/08/2023] Open
Abstract
Background Most older patients with acute myeloid leukemia (AML) who attain morphologic remission with intensive chemotherapy (IC) will eventually relapse and post-relapse prognosis is dismal. In the pivotal QUAZAR AML-001 trial, oral azacitidine maintenance therapy significantly prolonged overall survival by 9.9 months (P < 0.001) and relapse-free survival by 5.3 months (P < 0.001) compared with placebo in patients with AML in first remission after IC who were not candidates for transplant. Currently, the QUAZAR AML-001 trial provides the most comprehensive safety information associated with oral azacitidine maintenance therapy. Reviewed here are common adverse events (AEs) during oral azacitidine treatment in QUAZAR AML-001, and practical recommendations for AE management based on guidance from international cancer consortiums, regulatory authorities, and the authors’ clinical experience treating patients in the trial. Methods QUAZAR AML-001 is an international, placebo-controlled randomized phase 3 study. Patients aged ≥ 55 years with AML and intermediate- or poor-risk cytogenetics at diagnosis, who had attained first complete remission (CR) or CR with incomplete blood count recovery (CRi) within 4 months before study entry, were randomized 1:1 to receive oral azacitidine 300 mg or placebo once-daily for 14 days in repeated 28-day cycles. Safety was assessed in all patients who received ≥ 1 dose of study drug. Results A total of 469 patients received oral azacitidine (n = 236) or placebo (n = 233). Median age was 68 years. Patients received a median of 12 (range 1–80) oral azacitidine treatment cycles or 6 (1–73) placebo cycles. Gastrointestinal AEs were common and typically low-grade. The most frequent grade 3–4 AEs during oral azacitidine therapy were hematologic events. AEs infrequently required permanent discontinuation of oral azacitidine (13%), suggesting they were effectively managed with use of concomitant medications and oral azacitidine dosing modifications. Conclusion Oral azacitidine maintenance had a generally favorable safety profile. Prophylaxis with antiemetic agents, and blood count monitoring every other week, are recommended for at least the first 2 oral azacitidine treatment cycles, and as needed thereafter. Awareness of the type, onset, and duration of common AEs, and implementation of effective AE management, may maximize treatment adherence and optimize the survival benefits of oral azacitidine AML remission maintenance therapy. Trial registration This trial is registered on clinicaltrials.gov: NCT01757535 as of December 2012. Supplementary Information The online version contains supplementary material available at 10.1186/s13045-021-01142-x.
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Affiliation(s)
- Farhad Ravandi
- Department of Leukemia, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA.
| | - Gail J Roboz
- Weill Cornell Medicine, New York, NY, USA.,New York Presbyterian Hospital, New York, NY, USA
| | - Andrew H Wei
- Department of Clinical Haematology, The Alfred Hospital, Melbourne, Australia.,Australian Centre for Blood Diseases, Monash University, Melbourne, Australia
| | - Hartmut Döhner
- Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany
| | | | | | - Pau Montesinos
- Hospital Universitari i Politècnic La Fe, Valencia, Spain
| | - Hamid Sayar
- Indiana University Cancer Center, Indianapolis, IN, USA
| | | | | | - Hana Safah
- Tulane University Health Science Center, New Orleans, LA, USA
| | - William Tse
- University of Louisville School of Medicine, Louisville, KY, USA
| | | | | | | | | | | | - Barry Skikne
- University of Kansas Medical Center, Kansas City, KS, USA.,Bristol Myers Squibb, Princeton, NJ, USA
| | | | | | - C L Beach
- Bristol Myers Squibb, Princeton, NJ, USA
| | - Herve Dombret
- Hôpital Saint-Louis, Assistance Publique - Hôpitaux de Paris (AP-HP), Paris, France.,Institut de Recherche Saint-Louis, Université de Paris, Paris, France
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50
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Kawakami K, Aoyama T, Yokokawa T, Kobayashi K, Takahari D, Chin K, Ide T, Machida Y, Yamaguchi K, Hama T. The Combined Use of 5 or More Drugs Is a Factor Related to Lower Adherence to S-1 in S-1 and Oxaliplatin Treatment for Advanced Gastric Cancer. Biol Pharm Bull 2021; 44:1075-1080. [PMID: 34334492 DOI: 10.1248/bpb.b21-00184] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
Abstract
S-1 plus oxaliplatin (SOX) is an established treatment for advanced gastric cancer. S-1 adherence is the key to successful SOX treatment. This study focused on S-1 adherence by evaluating real-world adherence to S-1 and investigating factors related to decreased S-1 adherence. This study included cases treated between August 1, 2014 and October 12, 2016 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research. The S-1 adherence rate per cycle was defined as the number of times a patient took S-1/28. In this study, adherence to S-1 was assessed through pill counts and by asking the patient about the reason for non-adherence at a pharmaceutical outpatient clinic. Univariate and multivariate analyses were performed to investigate factors influencing lower adherence. This analysis included 116 patients evaluated for adherence to S-1 on SOX treatment. The median rate of adherence to S-1 was 92.8% in the first cycle and 90.5% in the seventh cycle. The median relative dose intensity of S-1 was 84.6%. In terms of reasons for nonadherence, patients most commonly cited nausea/vomiting (43.7%), diarrhea (20.8%), missed dose (11.8%), and fever (8.1%). Logistic regression analysis was performed using the most appropriate regression equation, and a significant association was detected with 1 factor, number of combined drugs ≥5 (odds ratio (OR) = 2.50; 95% confidence interval (CI), 1.04-6.03, p = 0.04). Eliminating unnecessary concomitant medications helps maintain proper adherence to S-1 in SOX treatment.
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Affiliation(s)
- Kazuyoshi Kawakami
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Takeshi Aoyama
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Takashi Yokokawa
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Kazuo Kobayashi
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Daisuke Takahari
- Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Keisho Chin
- Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Tsugumi Ide
- Section for Practical Education, Hoshi University School of Pharmacy and Pharmaceutical Sciences
| | - Yoshiaki Machida
- Section for Practical Education, Hoshi University School of Pharmacy and Pharmaceutical Sciences
| | - Kensei Yamaguchi
- Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
| | - Toshihiro Hama
- Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
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