James Hernon1. 1. Norfolk and Norwich University Hospitals NHS Foundation Trust, Colney Lane, Norwich, NR4 7UY.
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 post-operative exercise on post-operative recovery outcomes and longer-term health-related quality of life are unknown, thus there is a need for high quality randomised controlled trials. METHOD:SupPoRtive Exercise Programmes for Accelerating REcovery after major Abdominal Cancer surgery (PREPARE-ABC) is a 3-arm multi-centre randomised controlled trial with internal pilot. The primary objective is to assess the effects of pre- and post-operative exercise on surgical outcomes and longer-term health-related quality of life in cancer patients undergoing colorectal resection. PREPARE-ABC aims to randomise 1146 patients at the individual level (1:1:1) to eitherhospital-supervised exercise, home-supported exercise or treatment as usual. The primary outcomes are short-term (30-day) morbidity using the Clavien-Dindo classification and longer-term health-related quality of life using the Medical Outcomes Study Health Questionnaire (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 randomised controlled trial to investigate the effects of pre- and post-operative exercise on short-term post-operative 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. This article is protected by copyright. All rights reserved.
RCT Entities:
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 post-operative exercise on post-operative recovery outcomes and longer-term health-related quality of life are unknown, thus there is a need for high quality randomised controlled trials. METHOD: SupPoRtive Exercise Programmes for Accelerating REcovery after major Abdominal Cancer surgery (PREPARE-ABC) is a 3-arm multi-centre randomised controlled trial with internal pilot. The primary objective is to assess the effects of pre- and post-operative exercise on surgical outcomes and longer-term health-related quality of life in cancerpatients undergoing colorectal resection. PREPARE-ABC aims to randomise 1146 patients at the individual level (1:1:1) to either hospital-supervised exercise, home-supported exercise or treatment as usual. The primary outcomes are short-term (30-day) morbidity using the Clavien-Dindo classification and longer-term health-related quality of life using the Medical Outcomes Study Health Questionnaire (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 randomised controlled trial to investigate the effects of pre- and post-operative exercise on short-term post-operative health outcomes and longer-term health-related quality of life in colorectal cancerpatients. 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. This article is protected by copyright. All rights reserved.
Authors: John Saxton; James Hernon; Jamie Murdoch; Anna Varley; Jane McCulloch; Megan Jones; Laura B Thomas; Allan Clark; Susan Stirling; David Turner; Ann Marie Swart; Kerry Dresser; Gregory Howard Journal: BMC Cancer Date: 2021-10-23 Impact factor: 4.430