一个以社区药房为基础的项目,以提高乳腺癌幸存者对辅助内分泌治疗的依从性(PACHA):一项试点集群随机对照试验方案。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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

摘要

背景:辅助内分泌治疗(AET)是一种口服治疗,适用于激素敏感性乳腺癌患者5 - 10年。尽管AET在减少乳腺癌复发方面有好处,但不理想的依从性是常见的。社区药剂师可以在支持妇女接受这种治疗方面发挥作用,因为他们经常与患者接触,可以获得补充信息,并具有管理副作用的专业知识。这项试点研究的目的是评估PACHA项目的可接受性和实施可行性,以及初步效果。PACHA项目是一个以社区药房为基础的项目,旨在支持处方AET的妇女。另一个目标是评估大规模随机对照试验(RCT)的可行性。方法:这是一项使用混合方法的试点集群随机对照试验。集群由药房、药剂师和过去30个月内使用AET处方的患者组成。通过定向广告招募药店。参与的药店按1:1随机分为两组(每组33家药店)。在第一组(对照组)中,药剂师将为妇女提供常规服务。在第二组(干预)中,药剂师将完成基于网络的培训,并使用基于动机访谈原则的标准化指南和基于证据的在线策略表进行咨询,以应对AET的副作用。干预组的妇女可以访问一个网站,上面有关于AET的视频模块,管理副作用的策略,患有AET的妇女的证明,以及资源列表。可接受性和可行性指标,以及预期影响AET依从性和治疗经验的心理社会因素,将在基线、期间和6个月随访结束时通过在线问卷调查、研究数据日志和药房索赔记录收集。将进行半结构化访谈,以探讨参与者在项目中的经历。讨论:结果将有助于完善方案,如果结果支持这一点,设计一个全面的集群随机对照试验来评估方案对5年依从性和成本的影响。如果有效,该项目将填补乳腺癌支持性护理的空白,并通过改善幸存者的经历和生存来减轻癌症负担。试验注册:本试验已获得中国曲海-拉瓦尔大学研究伦理委员会(MP-20-2023-6625)的批准,并在研究开始前于2023-05-24,https://classic.Clinicaltrials: gov/ct2/show/NCT05887102在Clinicaltrials.gov (NCT05887102)上注册。协议版本1的日期为2022-12-12。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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.

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.

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.

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.

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.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
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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