THRIVE 研究方案：一项随机对照试验，评估一种基于网络的应用程序和个性化信息，以提高乳腺癌女性辅助内分泌治疗的依从性。

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer.

机构信息

Department of Health Policy and Management, Emory University, Rollins School of Public Health, 1518 Clifton Road, Atlanta, GA, USA.

The West Cancer Center & Research Institute, Memphis, TN, USA.

出版信息

BMC Health Serv Res. 2019 Dec 19;19(1):977. doi: 10.1186/s12913-019-4588-x.

DOI:10.1186/s12913-019-4588-x

PMID:31856812

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6924011/

Abstract

BACKGROUND

Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence.

METHODS

In this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an "App" group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an "App+Feedback" group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a "Usual Care" group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence.

DISCUSSION

A successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient care experience.

TRIAL REGISTRATION

NCT03592771. Prospectively registered on July 19, 2018.

摘要

背景

对于早期激素受体阳性乳腺癌女性，长期使用辅助内分泌治疗（AET）可显著降低住院、癌症复发和死亡风险。AET 会引起不良反应，这些不良反应往往导致患者服药的依从性降低。一种基于网络的应用程序为正在接受 AET 的女性提供了一种新颖的沟通和管理症状的方式。在一个乳腺癌治疗结果存在显著种族差异的地区，我们的研究测试了一种基于网络的应用程序，该应用程序可以收集和传输患者报告的症状，以帮助医疗团队及时、有效地管理症状，从而提高患者对药物的依从性。

方法

在这项随机对照试验中，我们将 300 名开始接受 AET 的患者随机分为三组：1）“应用程序”组（n=100），每周收到使用 THRIVE 研究应用程序的提醒；2）“应用程序+反馈”组（n=100），每周收到提醒，并根据他们使用应用程序的情况提供个性化反馈；3）“常规护理”组（n=100），仅接受常规护理。参与者按种族分层：50%为白人，50%为黑人。干预的持续时间为入组后 6 个月，结果在 12 个月时进行评估。主要结局是依从性，通过电子监测药盒来评估。次要结局包括症状负担、生活质量、管理症状的自我效能感和医疗保健成本。我们还评估了干预对依从性种族差异的影响。数据来自三个来源：电子健康记录数据，用于捕捉治疗变化、医疗保健利用和健康结果；与依从性、症状负担和生活质量相关的自我报告调查数据；以及一个电子药物监测设备，用于捕捉依从性。