SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE‐ABC): Study protocol for a multicentre randomized controlled trial

Abstract Background Exercise programmes can increase cardiopulmonary reserve and functional capacity prior to surgery and can improve clinical, functional and survival outcomes after a colorectal cancer diagnosis. However, the impact of pre‐ and postoperative exercise on postoperative recovery outcomes and longer‐term health‐related quality of life are unknown; thus, there is a need for high‐quality randomized controlled trials. Method SupPoRtive Exercise Programmes for Accelerating REcovery after major Abdominal Cancer surgery (PREPARE‐ABC) is a three‐arm multicentre randomized controlled trial with internal pilot. The primary objective is to assess the effects of pre‐ and postoperative exercise on surgical outcomes and longer‐term health‐related quality of life in cancer patients undergoing colorectal resection. The aim of PREPARE‐ABC is to randomize 1146 patients at the individual level (1:1:1) to hospital‐supervised exercise, home‐supported exercise or treatment as usual. The primary outcomes are short‐term (30‐day) morbidity, assessed using the Clavien–Dindo classification, and longer‐term health‐related quality of life, assessed using the Medical Outcomes Study Health Questionnaire (36‐item Short‐Form Survey [SF‐36]). Secondary outcomes include cardiopulmonary fitness, physical activity behaviour change, psychological health status and cost‐effectiveness. A process evaluation of intervention delivery and usual care also will be undertaken. Discussion This is the first UK‐based definitive randomized controlled trial to investigate the effects of pre‐ and postoperative exercise on short‐term postoperative health outcomes and longer‐term health‐related quality of life in colorectal cancer patients. The trial will yield robust clinical and cost‐effectiveness data to underpin clinical guidance on how exercise programmes should be implemented in the routine management of patients undergoing major colorectal cancer surgery.