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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,560
- Locations
- 1
- Primary Endpoint
- Post-operative length of hospital stay
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Masking of CPET assessors and dual reporting, masking of personnel involved in outcome data collection, masking of sarcopenia assessors
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
Usual care plus additional monitoring
SRETP
Structured Responsive Exercise Training Programme (SRETP) prior to surgery
Intervention: SRETP (Behavioral)
Psychological support
Psychological support prior to surgery
Intervention: Psychological support (Behavioral)
SRETP and psychological support
Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery
Intervention: SRETP (Behavioral)
SRETP and psychological support
Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery
Intervention: Psychological support (Behavioral)
Outcomes
Primary Outcomes
Post-operative length of hospital stay
Time Frame: up to 1 year
Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).
Secondary Outcomes
- 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)(up to 15 weeks)
- Overall survival - 1(1 year post-operatively)
- Overall survival -2(5 years post-operatively)
- Physical activity -1(Baseline up to 1 year post-operatively)
- Disease free survival(1 year post-operatively)
- Post-operative morbidity -1(POMS at day 3,5,7 and 15.)
- Post-operative morbidity -2(up to 1 year)
- Physical activity -2(Baseline up to 1 year post-operatively)
- Physical activity -3(Baseline up to 1 year post-operatively)
- Physical activity -4(Baseline up to 1 year post-operatively)
- Health related quality of life -1(Baseline up to 1 year post-operatively)
- Health related quality of life -2(Baseline up to 1 year post-operatively)
- Health related quality of life -3(Baseline up to 1 year post-operatively)
- Mental well being -1(Baseline up to 1 year post-operatively)
- Mental well being -2(Baseline up to 1 year post-operatively)
- Mental well being -3(Baseline up to 1 year post-operatively)
- Mental well being -4(Baseline up to 1 year post-operatively)
- Mental well being -5(Baseline up to 1 year post-operatively)
- Complex health interventions evaluation(Baseline up to 1 year post-operatively)
- Radiological markers of sarco-cachexia measured from routine CT scans(Baseline up to 1 year post-operatively)
- Toxicity and adverse events(Baseline up to 1 year post-operatively)
- Tumour outcomes -1(Baseline up to 1 year post-operatively)
- Tumour outcomes -2(Baseline up to 1 year post-operatively)
- Tumour outcomes -3(Baseline up to 1 year post-operatively)
- Tumour outcomes -4(Baseline up to 1 year post-operatively)
- Tumour outcomes -5(Baseline up to 1 year post-operatively)
- Tumour outcomes -6(Baseline up to 1 year post-operatively)
- Tumour outcomes -7(Baseline up to 1 year post-operatively)
- Tumour outcomes -8(Baseline up to 1 year post-operatively)
- Tumour outcomes -9(Baseline up to 1 year post-operatively)
- Tumour outcomes -10(Baseline up to 1 year post-operatively)
- Tumour outcomes -11(Baseline up to 1 year post-operatively)
- Tumour outcomes -12(Baseline up to 1 year post-operatively)
- Tumour outcomes -13(Baseline up to 1 year post-operatively)
- Tumour outcomes -14(Baseline up to 1 year post-operatively)
- Tumour outcomes -15(Baseline up to 1 year post-operatively)
- Nutrition -2(Baseline up to 1 year post-operatively)
- Tumour outcomes -16(Baseline up to 1 year post-operatively)
- Disability adjusted survival(Baseline up to 1 year post-operatively)
- Tumour microenvironment(Baseline up to 1 year post-operatively)
- Nutrition -1(Baseline up to 1 year post-operatively)
- Nutrition -3(Baseline up to 1 year post-operatively)
- Nutrition -4(Baseline up to 1 year post-operatively)