Abstract PO2-19-04: Trial in Progress: The REJOIN Trial to Use Exercise and Education to Relieve Joint Pain in Older Breast Cancer Survivors Taking Aromatase Inhibitors
Authors: Bluethmann Shirley , Newman Peri , Truica Cristina , Olsen Nancy , Klepin Heidi 
Published: May 2024

Background: Physical activity (PA) is a recommended part of breast cancer survivorship. PA promotes survival and mitigates symptoms in older breast cancer survivors (BCS), especially in reducing joint pain associated with Aromatase Inhibitors (AIs). The purpose of the study is to test if a self-management intervention (including education and exercise instruction) improve joint pain management better than standard care.

Trial Design: This two-armed randomized controlled pilot trial (NCT03955627) includes insufficiently active BCS, 60 years and older, diagnosed with stage I-III hormone-sensitive breast cancer, who have completed primary cancer treatment and are within 6 months of initiating AIs. We adapted an evidence-based PA program for older adults (Fit and Strong!) that includes bi-weekly, supervised exercise sessions plus education (90 minutes total). The 16-week, evidence-based intervention program includes: 8-weeks of supervised sessions delivered remotely plus 8-weeks of self-guided home sessions with periodic phone coaching. We are conducting select geriatric assessments (e.g., cognitive assessment, polypharmacy) plus measurements of exercise (both self-reported and objectively measured by accelerometer), joint pain (brief pain inventory), and AI adherence (confirmed by self-report and prescription records) assessed four times (baseline, 4, 6 and 12 months).

Eligibility Inclusion criteria: • Female, aged ≥ 60 years at enrollment  • Planning to initiate (or are &lt; 24 weeks from initiating) AIs  • Diagnosed stages I-III breast cancer  • ER+ tumor (at least 5% of cells)  • Completed surgery, radiation and/or chemotherapy  • Independent ambulator (verified by treating clinician/staff)  • Physician approval to start an exercise program • Insufficiently active (less than 150 minutes per week of moderate intensity activity or less than two sessions per week of strength training)  • Able to complete surveys and forms/understand English  • Agree to random assignment to treatment or control group  • Can commit to 8 weeks, bi-weekly classes offered by Zoom video and 8 Weeks of at-home exercise.  • Must have internet access or data plan to support video conferencing software  • Minimum cognitive impairment (verified by cognitive screening questions administered by phone)

Specific Aims: The primary aim is to test the efficacy of a self-management intervention (exercise plus education) on AI-associated arthralgia. Hypothesis: Participants in the treatment group will report less pain than the control group.

–A secondary aim is to test the effect of the pilot intervention on adherence to AIs. Hypothesis: Participants in the treatment group will report better AI Adherence than controls.

Statistical Methods: We will use the Wilcoxon-Mann-Whitney t-test to assess the effect size from the start to the end of the trial, assuming a power calculation of 80%, a two-sided alpha of 10%, and a pooled standard deviation of one between the outcomes of the two groups (usual care and treatment) being compared. Present Accrual and Target Accrual REJOIN enrolled 12 participants in 2022, but two withdrew after randomization. We now have data on 10 participants with a target accrual of 24 overall. The original 12 were accrued at Penn State College of Medicine. We subsequently opened a second site at Wake Forest University and are recruiting the remaining participants.

Contact information: For more information about REJOIN, please contact the study director, Dr. Shirley Bluethmann at sblueth@wakehealth.edu or the REJOIN project manager, Angela Grubb, at agrubb@wakehealth.edu

Citation Format: Shirley Bluethmann, Peri Newman, Cristina Truica, Nancy Olsen, Heidi Klepin. Trial in Progress: The REJOIN Trial to Use Exercise and Education to Relieve Joint Pain in Older Breast Cancer Survivors Taking Aromatase Inhibitors [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-19-04.