{"doc_desc":{"title":"A pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial","producers":[{"name":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","abbreviation":"Unisant\u00e9","affiliation":"","role":"Data publisher"}]},"study_desc":{"title_statement":{"idno":"10.16909-DATASET-45","title":"A pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial","alt_title":"OpTAT"},"authoring_entity":[{"name":"SCHNEIDER Marie, PI","affiliation":"1) Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Lausanne, Switzerland ; 2) School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland"},{"name":"CSAJKA Chantal, co-PI","affiliation":"Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland"},{"name":"WAGNER Dorothea, co-PI","affiliation":"Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland"}],"production_statement":{"producers":[{"name":"BANDIERA, Carole","affiliation":"1) Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Lausanne, Switzerland ; 2) School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland","role":"First author, PhD student"},{"name":"CARDOSO, Evelina","affiliation":"Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland","role":"Second author, PhD student (when study was launched)"},{"name":"LOCATELLI, Isabella","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Lausanne, Switzerland","role":"Statistician"},{"name":"PASQUIER, J\u00e9r\u00f4me","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Lausanne, Switzerland","role":"Second statistician"},{"name":"DOTTA-CELIO Jennifer","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Lausanne, Switzerland","role":"Representative of the Medication adherence program, pharmacy, Unisant\u00e9"},{"name":"PETERS, Solange","affiliation":"Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland","role":"Head of the service of medical oncology, CHUV"}],"funding_agencies":[{"name":"Swiss Cancer Research Foundation","abbreviation":"","role":"Grant HSR-4077-11-2016"}],"grant_no":"Grant HSR-4077-11-2016"},"version_statement":{"version":"Version : March 2024","version_date":""},"study_info":{"keywords":[{"keyword":"medication adherence","vocab":"","uri":""},{"keyword":"medication implementation","vocab":"","uri":""},{"keyword":"medication adherence program","vocab":"","uri":""},{"keyword":"oral oncology","vocab":"","uri":""},{"keyword":"cancer","vocab":"","uri":""},{"keyword":"protein kinase inhibitors","vocab":"","uri":""},{"keyword":"interprofessional collaboration","vocab":"","uri":""}],"abstract":"Background : Oral anticancer therapies such as protein kinase inhibitors (PKIs) are increasingly prescribed in cancer care. We aimed to evaluate the impact of a pharmacist-led interprofessional medication adherence program (IMAP) on patient implementation (dosing history), persistence (time until premature cessation of the treatment) and adherence to 27 PKIs prescribed for various solid cancers, as well as the impact on patients\u2019 beliefs about medicines (BAM) and quality of life (QoL). \n\n\t\tMethods : Patients (n=118) were randomized 1:1 into two arms. In the intervention arm, pharmacists supported patient adherence through monthly electronic and motivational feedback, including educational, behavioral and affective components, for 12 months. The control arm received standard care plus EM without intervention. All PKIs were delivered in electronic monitors (EMs). Medication implementation and adherence were compared between groups using generalized estimating equation models, in which relevant covariables were included; persistence was compared with Kaplan\u2012Meier curves. Information on all treatment interruptions was compiled for the analysis. Questionnaires to evaluate BAM and QoL were completed among patients who refused and those who accepted to participate at inclusion, 6 and 12 months post-inclusion or at study exit.\n\nResults : Day-by-day PKI implementation was consistently higher and statistically significant in the intervention arm (n=58) than in the control arm (n=60), with 98.1% and 95.0% (\u03943.1%, 95% confidence interval (CI) of the difference 2.5%; 3.7%) implementation at 6 months, respectively. The probabilities of persistence and adherence were not different between groups, and no difference was found between groups for BAM and QoL scores. No difference in BAM or QoL was found among patients who refused versus those who participated. The intervention benefited mostly men (at 6 months, \u03944.7%, 95% CI 3.4%; 6.0%), those younger than 60 years (\u03944.0%, 95% CI 3.1%; 4.9%), those who had initiated PKI more than 60 days ago before inclusion (\u03944.5%, 95% CI 3.6%; 5.4%), patients without metastasis (\u03944.5%, 95% CI 3.4%; 5.7%), those who were diagnosed with metastasis more than 2 years ago (\u03945.3%, 95% CI 4.3%; 6.4%) and those who had never used any adherence tool before inclusion (\u03943.8%, 95% CI 3.1%; 4.5%).\n\nConclusions : The IMAP, led by pharmacists in the context of an interprofessional collaborative practice, supported adherence, specifically implementation, to PKIs among patients with solid cancers. To manage adverse drug events, PKI transient interruptions are often mandated as part of a strategy for treatment and adherence optimization according to guidelines. Implementation of longer-term medication adherence interventions in the daily clinic may contribute to the improvement of progression-free survival.","coll_dates":[{"start":"2015\/07\/24","end":"2022\/05\/03","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"analysis_unit":"Each patient provides longitudinal dates and times of openings of their digital pillbox containing their oncology treatment during a maximal period of 12-13 months. Empirical adherence is defined on each day by the proportion of patients with a correct medication intake (outcome=1) among all patients initially included in this study, corresponding to the product between the probabilities of protein kinase inhibitor implementation and persistence on each day of the monitoring period.","universe":"Cancer patients over 18 years old. Pharmacy, clinical oncology, interpofessional collaboration, outpatient setting","data_kind":"Clinical data [cli]"},"method":{"data_collection":{"sampling_procedure":"The sample size calculation (n=120 patients, 60 in each group) is presented in the publication (protocol): Bandiera, C., et al., Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. JMIR Res Protoc, 2021. 10(6): p. e30090. Eligible patients were adults treated with at least one oral PKI for solid cancers. Patients were excluded if they did not self-manage their treatment (i.e., benefited from home care services or caregivers or were under tutelage) or if they were diagnosed with major cognitive impairments.","coll_mode":"PKIs (protein kinase inhibitors) adherence data were collected by electronic monitoring (Medication Event Monitoring System, MEMS and MEMS AS, AARDEX Group, Sion, Switzerland). Sociodemographic and clinical data were extracted from the CHUV Soarian database. Questionnaires were filled in by patients (quality of life and beliefs about medicines).","research_instrument":"Digital monitor called the Medication Event Monitoring System, MEMS and MEMS AS, AARDEX Group, Sion, Switzerland. \nRedCAP for data collection. \nValidated questionnaires (EORTC-QLQ for quality of life and BMQ: Belief about Medicines Questionnaire)"}},"data_access":{"dataset_use":{"contact":[{"name":"Documentation and data Unit","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"udd.data@unisante.ch","uri":""},{"name":"SCHNEIDER, Marie","affiliation":"School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland","email":"marie.schneider@unige.ch","uri":""}],"cit_req":"BANDIERA, C., CARDOSO, E., LOCATELLI I., ZAMAN, K., DICIOLLA, A., DIGKLIA, A., STRAVODIMOU A., CRISTINA, V., AEDO-LOPEZ, V., DOLCAN, A., SARIVALASIS, A., BOUCHAAB, H., PASQUIER, J., DOTTA-CELIO,J., PETERS,S., WAGNER, D., CSAJKA, C., SCHNEIDER M.P. \nA pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial. Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (03\/2024), provided by the Unisant\u00e9 Research Data Repository. DOI:https:\/\/doi.org\/10.16909\/DATASET\/45","conditions":"The data presented in this study are not publicly available due to ethical reasons, as imposed by the Ethics Committee \"Commission cantonale d\u2019\u00e9thique de la recherche sur l\u2019\u00eatre humain\" (Vaud, Switzerland). Metadata and codebooks are available on this repository. For any questions, please contact the documentation and data unit at the Center for Primary Care and Public Health Unisant\u00e9 (Route de Berne 113, 1010 Lausanne), through the contact information stated above."}}},"schematype":"survey"}