Clinical trial NCT03509428: The Wessex Fit-4-Cancer Surgery Trial
Official title: A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Exercise
mortality
morbidity
surgery
colorectal
upper gastrointestinal
hepatobiliary
urology
lung
nutrition
psychology
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
name: Hampshire Hospitals NHS Foundation Trust
name: Poole Hospital NHS Foundation Trust
name: Isle of Wight NHS Trust
name: Dorset County Hospital NHS Foundation Trust
First posted: 2018-04-26
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design randomised controlled interventional trial
Primary purpose: TREATMENT

Brief summary: Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation

Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).

Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.

Secondary Objective:

To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).

Detailed description: Rationale: Fitter patients have better surgical outcomes. Poor physical fitness measured objectively using cardiopulmonary exercise testing has been associated with increased LOS, increased morbidity and mortality in many patient cohorts undergoing major cancer surgery. Chemotherapy and radiotherapy have detrimental effects on physical fitness, which may in turn have a detrimental effect on the patients' ability to withstand surgery. Research suggests psychological factors including depression and self-efficacy (confidence to manage cancer-related problems) prior to surgery predict recovery trajectories in health-related quality of life up to 2 years after major surgery for colorectal cancer.

The aim is to investigate whether SRETP (Prehabilitation) ± psychological support prior to and during cancer treatment before major elective surgery reduces LOS, increases survival and improves their ability to self manage. Additionally, we aim to see if this intervention can bring about long-term behavioural change in relation to physical activity.

Trial Design: Phase III: A pragmatic factorial design randomised controlled to assess the effectiveness of a prehabilitation programme delivered prior to cancer treatments and/or major cancer surgery in patients undergoing elective intra-cavity major cancer surgery in Wessex.

Sample size: 1560

Intervention:

1. An in-hospital transition to a community based Structured Responsive Exercise-Training Programme (SRETP) ± psychological support (delivered in community/ council gyms or Cancer Support Centers). The intervention/s will be delivered before surgery. Patients receiving neoadjuvant cancer treatments prior to surgery will receive the intervention during and after these treatments.
2. Control: Standard care with extra monitoring

Eligibility criteria: Inclusion Criteria:

* Male or female patients
* aged over 18 years old
* scheduled to have major intra-cavity cancer surgery with a curative intent, defined as thoracic, colorectal, oesophagogastric, urological and hepatobiliary (inc. pancreatic).
* surgery alone (unimodal)
* surgery combined (multimodal) with cancer treatments (neoadjuvant chemotherapy, chemoradiotherapy or immunotherapies).
* All patients deemed by the MDT as potentially curable or undergoing neoadjuvant cancer treatments prior to restaging and surgery.

Exclusion Criteria:

* Patients will be excluded if under the age of 18 years,
* if their tumour is considered surgically non- resectable,
* having absolute or relative contraindications to completing a CPET,
* patients are unable to perform CPET due to other coexisting acute illness or conditions (e.g. lower limb dysfunction),
* patients decline surgery,
* if their weight exceeds 145kg
* patients unable to give informed consent.
* Patients having \>2 mm ST depression if symptomatic or 4 mm if asymptomatic or \>1 mm ST elevation during any CPET will need to be withdrawn from study.

Primary outcomes:
measure: Post-operative length of hospital stay
timeFrame: up to 1 year
Secondary outcomes:
measure: Change in objectively measured cardiopulmonary exercise testing variables - Oxygen uptake at anaerobic threshold (ml/kg/min) and oxygen uptake at peak exercise (ml/kg/min)
timeFrame: up to 15 weeks
measure: Overall survival - 1
timeFrame: 1 year post-operatively
measure: Overall survival -2
timeFrame: 5 years post-operatively
measure: Disease free survival
timeFrame: 1 year post-operatively
measure: Post-operative morbidity -1
timeFrame: POMS at day 3,5,7 and 15.
measure: Post-operative morbidity -2
timeFrame: up to 1 year
measure: Physical activity -1
timeFrame: Baseline up to 1 year post-operatively
measure: Physical activity -2
timeFrame: Baseline up to 1 year post-operatively
measure: Physical activity -3
timeFrame: Baseline up to 1 year post-operatively
measure: Physical activity -4
timeFrame: Baseline up to 1 year post-operatively
measure: Health related quality of life -1
timeFrame: Baseline up to 1 year post-operatively
measure: Health related quality of life -2
timeFrame: Baseline up to 1 year post-operatively
measure: Health related quality of life -3
timeFrame: Baseline up to 1 year post-operatively
measure: Mental well being -1
timeFrame: Baseline up to 1 year post-operatively
measure: Mental well being -2
timeFrame: Baseline up to 1 year post-operatively
measure: Mental well being -3
timeFrame: Baseline up to 1 year post-operatively
measure: Mental well being -4
timeFrame: Baseline up to 1 year post-operatively
measure: Mental well being -5
timeFrame: Baseline up to 1 year post-operatively
measure: Complex health interventions evaluation
timeFrame: Baseline up to 1 year post-operatively
measure: Radiological markers of sarco-cachexia measured from routine CT scans
timeFrame: Baseline up to 1 year post-operatively
measure: Toxicity and adverse events
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -1
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -2
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -3
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -4
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -5
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -6
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -7
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -8
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -9
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -10
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -11
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -12
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -13
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -14
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -15
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour outcomes -16
timeFrame: Baseline up to 1 year post-operatively
measure: Disability adjusted survival
timeFrame: Baseline up to 1 year post-operatively
measure: Tumour microenvironment
timeFrame: Baseline up to 1 year post-operatively
measure: Nutrition -1
timeFrame: Baseline up to 1 year post-operatively
measure: Nutrition -2
timeFrame: Baseline up to 1 year post-operatively
measure: Nutrition -3
timeFrame: Baseline up to 1 year post-operatively
measure: Nutrition -4
timeFrame: Baseline up to 1 year post-operatively
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hopsitals Southampton
Study officials:
affiliation: University Hospitals Southampton NHS Foundation Trust
name: Samantha Leggett
role: STUDY_DIRECTOR
References:
citation: West M, Bates A, Grimmett C, Allen C, Green R, Hawkins L, Moyses H, Leggett S, Z H Levett D, Rickard S, Varkonyi-Sepp J, Williams F, Wootton S, Hayes M, P W Grocott M, Jack S. 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. F1000Res. 2021 Sep 21;10:952. doi: 10.12688/f1000research.55324.2. eCollection 2021.