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

Andrew J. Paladino, Janeane N. Anderson, Rebecca A. Krukowski, Teresa Waters, Mehmet Kocak, Carolyn Graff, Ryan Blue, Tameka N. Jones, Joanne Buzaglo, Gregory Vidal, Lee Schwartzberg, Ilana Graetz

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

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.

Original languageEnglish
Article number977
JournalBMC Health Services Research
Volume19
Issue number1
DOIs
StatePublished - Dec 19 2019

Bibliographical note

Funding Information:
This study is supported by a grant from the National Cancer Institute (1R01CA218155). The National Cancer Institute can be reached at 1–800–422-6237, or via e-mail at NCIinfo@nih.gov. The funding source had no role in the design of this study and will not have any role during its execution, analysis, interpretation of the data, or decision to submit results.

Funding Information:
participants will be recruited; participants complete study tasks for a minimum of a year (the primary study end-point), and up to 36 months, depending on how early in the trial they were enrolled. This study received approval from the University of Tennessee Health Science Center Institutional Review Board (IRB #: 17–05479-XP IAA).

Publisher Copyright:
© 2019 The Author(s).

Keywords

  • Adjuvant endocrine therapy
  • Breast cancer
  • Medication adherence
  • Mhealth
  • Patient-reported outcomes
  • Quality of life
  • Randomized controlled trial

ASJC Scopus subject areas

  • Health Policy

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