Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Academic Unit of Primary Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
BMJ Open. 2023 Feb 3;13(2):e069971. doi: 10.1136/bmjopen-2022-069971.
Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component.
The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 2 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data.
The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal.
ISRTCN10487576.
不遵守辅助内分泌治疗（AET）的乳腺癌女性死亡和复发风险增加。AET 依从性存在多种障碍，包括药物副作用、对药物的看法、记忆力和心理困扰。我们开发了四个干预组件，每个组件针对一个不同的障碍。这项初步试验是多阶段优化策略准备阶段的一部分，旨在确定关键试验参数，确定干预组件的依从性，确定结果和过程数据的可用性和可行性，估计计划结果测量的变异性，并估计开发和提供每个干预组件的成本。
四个干预组件如下：短信服务文本提醒（针对记忆）；书面信息传单（针对药物信念）；指导自助接受和承诺治疗计划（针对减少困扰的心理灵活性）和自我管理网站（针对副作用管理）。为了评估招募的可行性、干预组件的可接受性和结果数据的可用性，我们将采用 2 因子部分因子设计，进行嵌套过程评估，进行多站点探索性初步试验。我们将随机选择 80 名接受 AET 治疗的早期乳腺癌女性，将她们随机分为 8 种实验条件之一。这将确定他们接受的干预组件组合，范围从零到四个，所有条件都接受常规护理。感兴趣的主要结果包括药物依从性和生活质量。根据同意率、患者对干预组件的依从性和药物依从性数据的可用性的预设标准，将进入优化阶段。
该研究已由威尔士研究管理局研究伦理委员会 3 （21/WA/0322）进行审查。在随机分组之前，将获得所有患者的书面知情同意。该试验的结果将在同行评议的期刊上发表。
ISRTCN10487576。
