SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE‐ABC): Pilot phase of a multicentre randomised controlled trial

Abstract

Aim: PREPARE-ABC is a pragmatic multicentre randomised controlled trial including an internal pilot designed to assess the clinical and cost-effectiveness of pre-and postoperative exercise in relation to short-and longer-term postoperative recovery outcomes in colorectal cancer patients undergoing surgical resection. Here, we report on internal pilot phase data for the first 200 patients randomised to the trial, which included prespecified stop-go criteria used to inform the decision to progress to the fully powered trial by the funder.Methods: Eligible and consenting patients are randomly assigned (1:1:1) to hospitalsupervised exercise, home-supported exercise or treatment as usual (TAU). Randomisation is concealed but clinical teams providing treatment and participants are unmasked.Primary outcomes are 30-day morbidity (Clavien-Dindo) and 12-month health-related quality of life (Medical Outcomes Study Health Questionnaire). Here, we present findings from the prespecified pilot phase which assessed feasibility of site set up, recruitment, adherence and acceptability of trial processes to patients and site staff.

Feasibility of a tele-prehabilitation program in high-risk patients with colon or rectal cancer undergoing elective surgery: a feasibility study

“…Therefore, for high-risk patients, participation in center-based prehabilitation is often difficult (Thomas et al 2019 ). Among perceived barriers that hinder patients from participating in prehabilitation are the many hospital appointments (Agasi-Idenburg et al 2020 ; Beck et al 2021 ), finding time (Berkel et al 2022 ; Ferreira et al 2018 ), distance from the prehabilitation facility (Woodfield et al 2018 ), and transportation issues (Berkel et al 2022 ; Ferreira et al 2018 ; Prepare-Abc Trial Collaborative 2021 ).…”

CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer

“…The rate of recruitment was chosen based on the recruitment rate of another trial of prehabilitation in colorectal cancer and the average number of colorectal cancer resections per hospital [46]. The rate of retention was chosen based on the retention rate in that trial [46].The rates of engagement and adherence were based on a trial of this type of intervention in the general population [17,23]. In all the above, the decision for cutoffs included what was deemed as reasonable to allow progression to the definitive trial.…”

“…The rate of recruitment was chosen based on the recruitment rate of another trial of prehabilitation in colorectal cancer and the average number of colorectal cancer resections per hospital [46]. The rate of retention was chosen based on the retention rate in that trial [46].…”

“…For the potential of the feasibility trial to be realised, recruitment to target is key. Complex logistics and significant participant burden have been recruitment challenges in a previous randomised controlled trial of prehabilitation intervention which recruited 0.75 participants per centre per month and 51% of eligible patients [46]. Although these will be reduced by delivering and testing the CARE intervention remotely, some may remain.…”

Updates on enhanced recovery after surgery for radical cystectomy

“…Larger, multi-centered RCTs such as PREPARE-ABC and Prehab4cancer are being conducted in the colorectal and surgical oncology fields. 55 , 56 Much work remains to be done in refining a program that is not only beneficial but adherable for BC patients and implementable by clinical team members. Prehabilitation programs are resource-intensive and can require upfront financial investments, which can be prohibitive in certain circumstances.…”