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

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

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.

Keywords: Adjuvant endocrine therapy; Breast cancer; Medication adherence; Mhealth; Patient-reported outcomes; Quality of life; Randomized controlled trial.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • African Americans / statistics & numerical data
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / psychology
  • Combined Modality Therapy
  • Female
  • Humans
  • Internet / statistics & numerical data
  • Medication Adherence / statistics & numerical data
  • Mobile Applications*
  • Neoplasm Recurrence, Local / drug therapy
  • Patient Compliance
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Reminder Systems / statistics & numerical data
  • Self Report
  • Surveys and Questionnaires
  • Whites / statistics & numerical data

Associated data

  • ClinicalTrials.gov/NCT03592771