Abstract PS5-10-18: Trial in Progress: The Physical Activity Index (PAI) Feasibility Pilot Trial for Breast and Colon Cancer Survivors in North Carolina

Abstract BACKGROUND The majority of the 18 million U.S. cancer survivors do not meet recommended levels of physical activity (PA) or limit sedentary behavior in daily life. Cancer survivors, especially breast cancer survivors (BCS) and colon cancer survivors (CCS), are particularly at risk of insufficient PA and prolonged sitting, contributing to increased physical impairments, symptom burden, and elevated cancer risk. Completion of cancer treatment may represent a “teachable moment” for lifestyle change, yet many survivors lack behavioral guidance from clinical teams. Validated tools to assess and counsel survivors on PA and sedentary behavior are limited. A simple screener—the Physical Activity Index (PAI)—collects information on PA, strength training, and sedentary behavior and may be useful in clinical settings for monitoring patient behaviors and offering specific, tailored recommendations. This research tests the feasibility of intervening with the PAI at the teachable moment, using the screener, coaching, and self-monitoring tools (e.g., activity tracker and PAI “report card”) to increase PA and reduce sedentary behavior. METHODS The intervention includes standard survivorship follow-up care, a PA assessment using the PAI screener (shared with the provider), and five remote coaching consultations with a certified exercise physiologist. Participants also receive resistance bands and a Garmin activity tracker for home-based self-monitoring. TRIAL DESIGN This is a two-arm, 1:1 randomized pilot trial with waitlist control to assess feasibility. We plan to recruit 20 participants (10 BCS, 10 colon cancer survivors), ages ≥50, stages 0-III, within three years of diagnosis and post-treatment. The pilot spans 12 months, with a six-month active intervention. Standardized study measures (e.g., weekly PA, sedentary time, physical function) will be collected at baseline, 3, 6, 9, and 12 months. Waitlist control participants will begin the intervention at month 6 after two assessments. All participants will complete five total research assessments over one year. STATISTICAL METHODS Feasibility will be assessed through recruitment, retention, acceptability, and adherence benchmarks. Secondary analyses will examine changes in PA and sedentary behavior to inform future trials. Descriptive statistics will summarize behavioral outcomes, participant demographics, and potential confounders (e.g., cancer type, treatment, medications) by group. The primary analytic goal is to estimate standard deviations (SDs) for future power calculations. Additional analyses will include mixed ANCOVA models (baseline-adjusted) to evaluate trajectories of PA and sedentary time over time. Acceptability will be measured via participant satisfaction scores (1-10); scores ≥7 will reflect acceptability. If feasible, this intervention may offer a scalable tool to support lifestyle behavior change and symptom management among cancer survivors—especially BCS—ultimately improving recovery, quality of life, and long-term survivorship outcomes. All study procedures were approved by the IRB at Atrium Health Wake Forest Baptist Comprehensive Cancer Center. This trial is registered at ClinicalTrials.gov (NCT06340503). Citation Format: S. Bluethmann, J. Tooze, J. Evans, J. Katula, K. Wood, L. Hitinariansingh, C. Crotts, H. Klepin, S. Zakrzewski, R. Paluri, K. Kadakia, K. Ansley. Trial in Progress: The Physical Activity Index (PAI) Feasibility Pilot Trial for Breast and Colon Cancer Survivors in North Carolina [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-10-18