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 WestAndrew BatesChloe GrimmettCait AllenRichard GreenLesley HawkinsHelen MoysesSamantha LeggettDenny Z H LevettSally RickardJudit Varkonyi-SeppFran WilliamsStephen A WoottonMatthew HayesMicheal P W GrocottSandy JackPublished in: F1000Research (2021)
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 the first randomised controlled study investigating whether an 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).
Keyphrases
- study protocol
- papillary thyroid
- physical activity
- end stage renal disease
- patients undergoing
- high intensity
- patient reported outcomes
- body composition
- healthcare
- squamous cell
- randomized controlled trial
- clinical trial
- chronic kidney disease
- resistance training
- minimally invasive
- prognostic factors
- ejection fraction
- peritoneal dialysis
- newly diagnosed
- sleep quality
- open label
- squamous cell carcinoma
- palliative care
- machine learning
- coronary artery bypass
- cardiovascular disease
- depressive symptoms
- multiple sclerosis
- mental health
- public health
- preterm infants
- childhood cancer
- risk factors
- chronic pain
- cardiovascular events
- phase ii
- decision making
- adipose tissue
- insulin resistance
- double blind
- bone mineral density
- weight loss
- percutaneous coronary intervention
- free survival
- drug induced
- adverse drug
- surgical site infection