The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery

Malcolm West, Andrew Bates, Chloe Grimmett, Cait Allen, Richard Green, Lesley Hawkins, Helen Moyses, Samantha Leggett, Denny Z H Levett, Sally Rickard, Judit Varkonyi-Sepp, Fran Williams, Stephen Wootton, Matthew Hayes, Micheal P W Grocott, Sandy Jack, Malcolm West, Andrew Bates, Chloe Grimmett, Cait Allen, Richard Green, Lesley Hawkins, Helen Moyses, Samantha Leggett, Denny Z H Levett, Sally Rickard, Judit Varkonyi-Sepp, Fran Williams, Stephen Wootton, Matthew Hayes, Micheal P W Grocott, Sandy Jack

Abstract

Background: Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post-operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. Methods: WesFit is a pragmatic , 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. Conclusions: The WesFit trial will be a randomised controlled study investigating whether a high-intensity exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. ClinicalTrials.gov registration: NCT03509428 (26/04/2018).

Keywords: Cardiopulmonary Exercise Test; Chemoradiotherapy; Chemotherapy; Exercise; Neoadjuvant; Outcome; Physical activity; Prehabilitation; Psychological; Surgery; Wellbeing.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2022 West M et al.

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