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The Wessex Fit-4-Cancer Surgery Trial (WesFit)

U

University Hospital Southampton NHS Foundation Trust

Status

Unknown

Conditions

Cancer

Treatments

Behavioral: SRETP
Behavioral: Psychological support

Study type

Interventional

Funder types

Other

Identifiers

NCT03509428
RHM CRI 0360

Details and patient eligibility

About

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).

Full 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:

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. Control: Standard care with extra monitoring

Enrollment

1,560 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

1,560 participants in 4 patient groups

Control
No Intervention group
Description:
Usual care plus additional monitoring
SRETP
Experimental group
Description:
Structured Responsive Exercise Training Programme (SRETP) prior to surgery
Treatment:
Behavioral: SRETP
Psychological support
Experimental group
Description:
Psychological support prior to surgery
Treatment:
Behavioral: Psychological support
SRETP and psychological support
Experimental group
Description:
Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery
Treatment:
Behavioral: Psychological support
Behavioral: SRETP

Trial contacts and locations

1

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Central trial contact

Sandy Jack, PhD; Malcolm West, PhD

Data sourced from clinicaltrials.gov

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