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

TY - JOUR

T1 - SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE-ABC): Study protocol for a multicentre randomized controlled trial

AU - Hernon, James

AU - Saxton, John M.

AU - Jones, Megan

AU - Howard, Gregory

AU - Swart, Ann Marie

AU - Clark, Allan

AU - Stirling, Susan

AU - Turner, David

AU - Murdoch, Jamie

AU - Nortje, Jurgens

AU - Bach, Simon

AU - Fearnhead, Nicola

AU - Din, Farhat

AU - Stephens, Alan

AU - Lund, Jonathan

AU - Tou, Samson

AU - Kelly, Seamus

AU - Ziprin, Paul

AU - Dennis, Robert

AU - Smart, Neil

AU - Wordley, Anna

AU - Thomas, Laura

N1 - Funding Information: The PREPARE‐ABC trial is fully funded by National Institute for Health Research Health Technology Assessment Programme; Grant Number 14/192/53. Publisher Copyright: © 2021 The Association of Coloproctology of Great Britain and Ireland Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/10

Y1 - 2021/10

N2 - 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.

AB - 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.

KW - colorectal cancer

KW - exercise prehabilitation

KW - health-related quality of life

KW - postoperative recovery

UR - http://www.scopus.com/inward/record.url?scp=85114496407&partnerID=8YFLogxK

U2 - 10.1111/codi.15805

DO - 10.1111/codi.15805

M3 - Article

SN - 1462-8910

VL - 23

SP - 2750

EP - 2760

JO - COLORECTAL DISEASE

JF - COLORECTAL DISEASE

IS - 10

ER -