Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial

NCT07278622 | Recruiting

• 1 other identifier: RHM CRI0467
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

One in four patients requiring planned major surgery have complications. Prehabilitation; which involves increasing physical activity, improving nutrition and supporting emotional well-being prior to surgery can reduce these complications and improve recovery. Group preoperative prehabilitation classes (surgery schools) are advocated by the Centre for Perioperative Care and are standard care in many hospitals, despite a lack of evidence for their effectiveness in improving patient outcomes. In phase 1 an 2 of this research investigators used patient experiences and co-participatory methods to optimise an existing intervention to make it as acceptable and as engaging as possible. The resulting education package is called 'GoPREPARE' Investigators now intend to test the practicalities of trialing GoPREPARE on preoperative patients with cancer. 24 patients awaiting surgery will be recruited from University Hospital Plymouth and randomly allocated equally to: Group - GoPREPARE and Group 2- standard care. Participants will complete lifestyle questionnaires before during and after their hospital stay. To evaluate the experience, \~8 participants will be interviewed. 5 clinical staff involved in the trial will also take part in a focus group. The information collected will be analysed to assess if it is feasible to conduct a larger trial.

Conditions

Cancer Surgery; Elective Surgery; Patient Education; Prehabilitation

Keywords

surgery school; prehabilitation; patient education; perioperative care

Outcome Measures

Primary Outcomes (6)

• Feasibility Outcome Measure: Proportion of eligible patients recruited

  E.g. number recruited compared with number eligible.

  From start of recruitment to recruitment closing. Approximately 6 months

• Feasibility Outcome Measure: Number of patients who decline and reasons for decline

  Number of patients who decline to take part in the study and reasons.

  During recruitment period approximately 6 months

• Feasibility Outcome Measure: Number of missed eligible patients

  Number of eligible patients not approached and reasons.

  From start of trial to recruitment closing. Approximately 6 months

• Feasibility Outcome Measure: Number of patients who remain in the trial for the full duration

  Retention of participants to trial and follow up. E.g. number of patients who remain in the trial until the follow up completed.

  From recruitment through to three month post surgery follow up. (Approx 4 months total)

• Feasibility Outcome Measure: Participant experience of GoPREPARE

  Participant experience of GoPREPARE. Interviews will be undertaken and experience captured through qualitative thematic analysis.

  2 months after surgery, approximately 3 months after enrollment

• Feasibility Outcome Measure: Staff experiences of taking part in GoPREPARE trial

  Staff experiences of delivering GoPREPARE trial. A focus group will be conducted at the end of the trial and experiences captured through thematic qualitative analysis.

  At end of recruitment period. Approximately months 6-8

Secondary Outcomes (14)

• Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires

  From recruitment through to three month post surgery follow up. (Approx 4 months total)

• Suitability and sensitivity of outcome measures: Average time participants wear their accelerometer

  From recruitment for two weeks, for one further week at around 3 months post surgery.

• Suitability and sensitivity of outcome measures: Adverse events

  From recruitment through to three month post surgery follow up. (Approx 4 months total)

• Suitability and sensitivity of outcome measures: Number of days spent in hospital following surgery

  In hospital stay approx 3-5 weeks following recruitment

• Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality

  From discharge from hospital to three month follow up

Study Arms (2)

GoPREPARE Education Intervention

EXPERIMENTAL

A 1.5 live education webinar delivered to groups of patients and their carers before surgery. Delivered by health care professionals.

Other: GoPREPARE

Standard Care

NO INTERVENTION

Patients will be given a standard prehabilitation leaflet

Interventions

GoPREPARE OTHER

GoPREPARE is a live interactive virtual education and behaviour change intervention delivered by healthcare professionals to groups of patients and their family, friends and carers which aims to prepare them for major cancer surgery.

GoPREPARE Education Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing elective surgery for any body cavity cancer with curative intent.
• Adults with more than 3 weeks before planned surgery
• Adults without previous experience of prehabilitation.

You may not qualify if:

• Children
• Adults who lack mental capacity.
• Adults who do not understand spoken English.
• Previous experience of prehabilitation.
• Previous surgery for cancer
• Pregnancy

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University Hospital Plymouth NHS Trust: collaborator
• University of Southampton: collaborator

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

RECRUITING

Study Officials

• Denny Z Levett, PhD

  Universal Hospital Southampton NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Imogen C Fecher-Jones, MSc

CONTACT

+447590270743; Imogen.fecher@uhs.nhs.uk

Sharon Davies-Dear

CONTACT

+442381205213; sharon.davies-dear@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention versus standard care

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: December 12, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)