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
| Autor: | Micheal P W Grocott, Fran Williams, Sandy Jack, A. Bates, Samantha Leggett, Cait Allen, Sally Rickard, Lesley Hawkins, Stephen A. Wootton, Chloe Grimmett, Malcolm A. West, Denny Z. H. Levett, Helen Moyses, Matthew M. Hayes, Richard Green, Judit Varkonyi-Sepp |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
medicine.medical_specialty
viruses Prehabilitation Physical fitness Psychological intervention Interval training General Biochemistry Genetics and Molecular Biology law.invention Quality of life Randomized controlled trial law Neoplasms Preoperative Care medicine Humans Multicenter Studies as Topic General Pharmacology Toxicology and Pharmaceutics Randomized Controlled Trials as Topic General Immunology and Microbiology business.industry Cancer Preoperative Exercise General Medicine biochemical phenomena metabolism and nutrition medicine.disease Research Design Physical therapy Quality of Life business Chemoradiotherapy |
| Popis: | 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) |
| Databáze: | OpenAIRE |
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