A community pharmacy-based program to enhance adherence to adjuvant endocrine therapy among breast cancer survivors (PACHA): protocol for a pilot cluster-randomized controlled trial.
Julie Lapointe, Laurence Guillaumie, Anne Dionne, Lyne Lalonde, Julie Lemieux, Michel Dorval, Hermann Nabi, Martine Lemay, Line Guénette, Jason Robert Guertin, Benoît Mâsse, Sophie Lauzier
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引用次数: 0
Abstract
Background: Adjuvant endocrine therapy (AET) is an oral treatment prescribed for 5 to 10 years to women with hormone-sensitive breast cancer. Despite the benefits of AET for reducing breast cancer recurrence, suboptimal adherence is common. Community pharmacists can play a role in supporting women with this treatment, given their frequent encounters with patients, access to refill information, and expertise in managing side effects. The goal of this pilot study is to assess the acceptability and feasibility of implementation, and preliminary effects of the PACHA program, a community pharmacy-based program designed to support women who are prescribed AET. Another goal is to assess the feasibility of a large-scale randomized controlled trial (RCT).
Methods: This is a pilot cluster-RCT using mixed-methods. A cluster consists of a pharmacy, its pharmacists, and its patients with an AET prescription in the last 30 months. Pharmacies will be recruited through targeted advertisement. Participating pharmacies will be randomized 1:1 to two groups (n = 33 pharmacies per group). In the first group (control), pharmacists will provide usual services to women. In the second group (intervention), pharmacists will complete web-based training and perform consultations using a standardized guide based on motivational interviewing principles and evidence-based online strategy sheets to cope with AET side effects. Women in the intervention group will have access to a website featuring video modules on AET, strategies for managing side effects, testimonials from women who have had an AET, and a list of resources. Acceptability and feasibility indicators, as well as psychosocial factors expected to influence AET adherence and treatment experience, will be collected at baseline, during, and at the end of the 6-month follow-up using online questionnaires, study data logs, and pharmacy claim records. Semi-structured interviews will be conducted to explore participants' experiences with the program.
Discussion: Results will help to refine the program and, if the results support this, to design a full-scale cluster-RCT to assess the program's effect on 5-year adherence and costs. If effective, this program could fill a gap in breast cancer supportive care and contribute to reducing cancer burden by improving survivorship experience and survival.
Trial registration: This trial has been approved by the Research Ethics Board of the CHU de Québec-Université Laval (MP-20-2023-6625) and registered at Clinicaltrials.gov (NCT05887102) on 2023-05-24, https://classic.
Clinicaltrials: gov/ct2/show/NCT05887102 , prior to beginning the study. Protocol version 1 is dated as 2022-12-12.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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