ABSTRACT
Aims: To determine the efficacy of physical activity (PA) in reducing disease recurrence in patients with localised colon cancer. Our primary hypothesis is that a PA program will improve disease-free survival (DFS) in patients with resected stage II (high risk) and III colon cancer who have completed adjuvant therapy. In addition, we hypothesise that exercise can improve fatigue, quality of life (QOL), physical functioning and body composition. Methods : An international multi-centre phase 3 RCT primarily between Australia and Canada. Subjects are randomised to PA program or standard care. Primary objective compares DFS between patients in PA and control arms. Key secondary objectives are to compare: 1. fatigue, QOL, depression, anxiety, sleep, body composition, exercise behaviour and fitness;2. overall survival (OS);3. association of cytokines, and insulin axis levels with PA, fatigue, and DFS;4. Health economic evaluation of the PA intervention. The study intervention is a 36-month PA programme aiming to achieve > 10 metabolic equivalent rates/week above baseline. Study assessments include: Disease status, fitness, body composition, QOL questionnaires at 0/6/12/18/24/30/36 months. Then annual patient reported outcomes and disease status until study closure. Interim analysis (n = 273 with 12 months follow up) showed good intervention adherence, significant difference in PA with 10.5 MET hours/week difference between groups, and objective fitness improvements in PA group. Adaptations due to COVID: In 2020, rapid amendments were made in response to COVID-19 to provide alternative modes for intervention delivery (via phone or virtual) and assessments conducted virtually where possible, with option of electronic completion of patient-reported outcomes. Current Status: Number of randomisations = 792 (82% of planned sample size);270 from Australia (from 24 sites). Five sites continue recruitment in Australia: Concord, Royal Brisbane and Women's, Tamworth, Newcastle Private, and Northern Cancer Institute.