Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial (GoPREPARE)

Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Education; Prehabilitation; Elective Surgery; Cancer Surgery
• Intervention / Treatment: Other: GoPREPARE

Detailed Description

See uploaded protocol

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imogen C Fecher-Jones, MSc; Phone Number: +447590270743; Email: Imogen.fecher@uhs.nhs.uk
• Study Contact Backup: Name: Sharon Davies-Dear; Phone Number: +442381205213; Email: sharon.davies-dear@uhs.nhs.uk

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Recruiting
      • University Hospitals Plymouth NHS Trust
      • Contact: Elinor Pegg; Phone Number: 07590270743; Email: elinor.pegg1@nhs.net
      • Contact: Helen Anderson; Phone Number: 07590270743; Email: Helen.anderson12@nhs.net
      • Principal Investigator: Steve Evans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GoPREPARE Education Intervention; A 1.5 live education webinar delivered to groups of patients and their carers before surgery. Delivered by health care professionals.	Other: GoPREPARE; 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.
No Intervention: Standard Care; Patients will be given a standard prehabilitation leaflet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires	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	Participant compliance with wearing accelerometer and usefulness of data collected.	From recruitment for two weeks, for one further week at around 3 months post surgery.
Suitability and sensitivity of outcome measures: Adverse events	Documentation of adverse events occurring during trial duration	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	Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS)	In hospital stay approx 3-5 weeks following recruitment
Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality	On day of discharge and at 3 month follow up patient's surgical complications (if any) will be graded using the Clavien-Dindo classification of surgical complications This classification is used to assess overall hospital morbidity following surgical procedures. Patients are graded as 0 (no complications) or Grade I-V based on the level of complication, including the number of organ system involvement. Grade V is defined as death of a patient. A record of the Comprehensive Complication Index (CCI) - an update of the Clavien-Dindo classification will also be collected.	From discharge from hospital to three month follow up
Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance	Post-operative recovery behaviour compliance measured using a questionnaire to capture frequency of postoperative breathing exercises, and the restarting of eating, drinking and mobilising by day three post surgery questionnaire	First three days after having had surgery
Suitability and sensitivity of outcome measures: Physical Activity 1	Number of steps while active using a triaxial accelerometer eg. Actigraph	At baseline for two weeks and at three months post surgery
Suitability and Sensitivity of Outcome Measures: Physical Activity 2	Godin Leisure Time and Exercise questionnaire - A self-reported measure of physical activity	At baseline, prior to admission for surgery and at 3 months post surgery
Suitability and Sensitivity of Outcome Measures: Health Related Quality of Life	Changes in health related quality of life measurements using validated questionnaires; including: EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys	At baseline, prior to admission for surgery and at three month follow up post surgery.
Suitability and Sensitivity of Outcome Measures: Nutrition 1	Height (cms) and weight (kg) will be combined to report BMI in kg/m^2	At baseline, before admission to hospital for surgery and at three month follow up post surgery
Suitability and Sensitivity of Outcome Measures: Nutrition 2	Patient self-completing Worldwide Cancer Research (WCRF) Screening and food frequency questionnaire. This asks about things like diet, processed foods, meat, drinks, answers can then be used to score how closely the lifestyle follows WCRF's cancer-prevention recommendations.	At baseline, prior to admission for surgery and at three month follow up post surgery
Suitability and Sensitivity of Outcome Measures: Mental Well-being	Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS) A tick box questionnaire relating to anxieties and depression that a patient might have felt over the past week. Choices are most of the time, a lot of the time, from time to time, and not at all for most questions.	At baseline, before admission to hospital for surgery and at three month follow up post surgery
Suitability and Sensitivity of Outcomes Measures: Smoking	Smoking habits measured using GATS (Global Adult Tobacco Survey) It asks about smoking and smokeless tobacco use, quitting habits and exposure to secondhand smoke.	At baseline, preadmission for surgery and three months follow-up post surgery.
Suitability and sensitivity of outcome measure: Alcohol Intake	Alcohol intake to be measured using the AUDIT-C is a short alcohol screening test used to check whether someone's drinking might be risky or harmful.	At baseline, preadmission for surgery and at three month follow-up post surgery.

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: University of Southampton; University Hospital Plymouth NHS Trust
• Investigators: Study Director: Denny Z Levett, PhD, Universal Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: patient education; prehabilitation; perioperative care; surgery school
• Other Study ID Numbers: RHM CRI0467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data including demographics or participants and direct quotes following the process evaluation interviews will be shared in academic journals. All data will be anonymised.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No