Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial

Abstract

Background: Aromatase Inhibitors (AIs) are recommended for survival in post-menopausal breast cancer survivors (BCS) with hormone-sensitive disease. AI Adherence is suboptimal, especially in older BCS. Joint pain is a common AI-related symptom that is associated with low AI adherence. The Using Exercise to Relieve Joint Pain in Older Breast Cancer Survivors (REJOIN) Trial will evaluate the efficacy of a self-management intervention (exercise + education) to increase knowledge/self-efficacy for symptom management, reduce joint pain and potentially increase AI adherence in older BCS planning to take AIs.

Methods: This randomized controlled pilot trial will include sedentary BCS, 65 years and older, diagnosed with stage I-III hormone-sensitive breast cancer, who have completed primary cancer treatment and are planning to initiate AIs. We will adapt an evidence-based physical activity program for older adults that includes bi-weekly, supervised exercise sessions plus 30 min of education. The 16-week intervention program includes: 8-weeks of supervised sessions plus 8-weeks of self-guided home sessions with periodic phone coaching. We will conduct geriatric assessments plus measurements of exercise, joint pain, and AI adherence (baseline, 4, 6 and 12 months).

Discussion: REJOIN is one of the first trials to exclusively target older BCS using a self-management intervention, informed by geriatric assessment and exercise physiology, to improve health outcomes in survivorship. The REJOIN trial could lay the foundation for transdisciplinary research that bridges the gap between clinical and public health perspectives in healthy aging, with the opportunity to translate clinical interventions into non-pharmacological tools for a growing, yet underserved population of older survivors.

Trial registration: NCT03955627.

Keywords: AI-related arthralgia; Breast cancer survivors; Geriatric oncology; Joint pain; Physical activity.

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2021 Elsevier Ltd. All rights reserved.

Figures

Figure 1.. Diagram of Intervention

AI = Aromatase Inhibitors;Rx = Prescription; PA = Physical Activity

Figure 2.. Conceptual Model for REJOIN (derived from Social Cognitive Theory)

REJOIN =The Using Exercise toRelieveJoint Pain and Improve AI Adherence in Older Breast Cancer Survivors (REJOIN) trial AI = Aromatase Inhibitors