University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
, Chapel Hill, USA.
Trials. 2023 Oct 12;24(1):664. doi: 10.1186/s13063-023-07672-8.
Hormone receptor-positive (HR +) breast cancer is the most common type of breast cancer in the USA but has excellent long-term outcomes in recent decades, in part due to effective oral endocrine therapy (ET). ET medications are typically prescribed for 5 to 10 years, depending on the risk of recurrence, and must be taken daily. One limiting factor to ET efficacy is nonadherence, with high-risk groups for nonadherence including younger women and Black women.
The Alliance for Clinical Trials in Oncology (Alliance) trial A191901 is an ongoing, four-arm (text message reminder (TMR), motivational interviewing (MI), TMR plus MI, or enhanced usual care) randomized clinical trial that tests the efficacy and effect of two interventions (TMR and/or MI) on improved ET adherence, patient-reported outcomes (PROs), and resource use requirements among HR + breast cancer survivors. Participants are randomized in a 1:1:1:1 ratio to the four arms. With an assumed loss to follow-up of approximately 11%, we plan to recruit 1180 participants. Randomization is stratified based on age and race to ensure balance between the arms, and we oversample younger and Black women, with each group representing 30% of the study population. Participants randomized to an intervention will actively participate in the intervention for 9 months, and all participants will be followed for adherence data and PRO endpoints, through the use of the Pillsy cap medication event monitoring system and Alliance ePRO survey app (i.e., Patient Cloud). The primary analysis will compare Pillsy-measured ET adherence among study arms at 12 months.
This multisite study will not only define strategies to improve adherence to breast cancer oral therapies, but it will also potentially support strategies in large cooperative research groups that can increase delivery and tolerability of ET, involve diverse patient populations in clinical research, and engage patients effectively in interventional studies, using remote and cost-effective delivery methods.
Clinicaltrials.gov NCT04379570 . Registered on 7 May 2020.
激素受体阳性（HR+）乳腺癌是美国最常见的乳腺癌类型，但在最近几十年，由于有效的口服内分泌治疗（ET），其长期预后良好。ET 药物通常根据复发风险，开 5-10 年的处方，必须每天服用。ET 疗效的一个限制因素是不依从，不依从的高风险人群包括年轻女性和黑人女性。
肿瘤临床研究联盟（Alliance）试验 A191901 是一项正在进行的、四项手臂（短信提醒（TMR）、动机性访谈（MI）、TMR 加 MI 或增强常规护理）随机临床试验，旨在测试两种干预措施（TMR 和/或 MI）对改善 ET 依从性、患者报告结局（PROs）和资源使用需求的疗效和效果。HR+乳腺癌幸存者。参与者按照 1:1:1:1 的比例随机分配到四个组。考虑到随访损失约为 11%，我们计划招募 1180 名参与者。随机分组基于年龄和种族进行分层，以确保各组之间的平衡，并且我们对年轻和黑人女性进行了超额抽样，每组占研究人群的 30%。随机分配到干预组的参与者将积极参与干预 9 个月，所有参与者将通过使用 Pillsy 帽药物事件监测系统和 Alliance ePRO 调查应用程序（即 Patient Cloud），随访依从性数据和 PRO 终点。主要分析将比较 12 个月时研究组中 Pillsy 测量的 ET 依从性。
这项多中心研究不仅将定义改善乳腺癌口服治疗依从性的策略，而且还可能支持大型合作研究小组的策略，这些策略可以提高 ET 的可及性和耐受性，使不同患者群体参与临床研究，并使用远程和具有成本效益的方法有效地让患者参与干预研究。
Clinicaltrials.gov NCT04379570。注册于 2020 年 5 月 7 日。
