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NCT Number: NCT07278622

Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

See uploaded protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility Outcome Measure: Proportion of eligible patients recruited

    Time frame: From start of recruitment to recruitment closing. Approximately 6 months

    E.g. number recruited compared with number eligible.

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

    Time frame: During recruitment period approximately 6 months

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

  3. Feasibility Outcome Measure: Number of missed eligible patients

    Time frame: From start of trial to recruitment closing. Approximately 6 months

    Number of eligible patients not approached and reasons.

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

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

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

  5. Feasibility Outcome Measure: Participant experience of GoPREPARE

    Time frame: 2 months after surgery, approximately 3 months after enrollment

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

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

    Time frame: At end of recruitment period. Approximately months 6-8

    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.

Secondary outcomes

  1. Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires

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

    Return rate and completeness of questionnaires.

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

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

    Participant compliance with wearing accelerometer and usefulness of data collected.

  3. Suitability and sensitivity of outcome measures: Adverse events

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

    Documentation of adverse events occurring during trial duration

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

    Time frame: In hospital stay approx 3-5 weeks following recruitment

    Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS)

  5. Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality

    Time frame: From discharge from hospital to three month follow up

    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.

  6. Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance

    Time frame: First three days after having had surgery

    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

  7. Suitability and sensitivity of outcome measures: Physical Activity 1

    Time frame: At baseline for two weeks and at three months post surgery

    Number of steps while active using a triaxial accelerometer eg. Actigraph

  8. Suitability and Sensitivity of Outcome Measures: Physical Activity 2

    Time frame: At baseline, prior to admission for surgery and at 3 months post surgery

    Godin Leisure Time and Exercise questionnaire - A self-reported measure of physical activity

  9. Suitability and Sensitivity of Outcome Measures: Health Related Quality of Life

    Time frame: At baseline, prior to admission for surgery and at three month follow up post surgery.

    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

  10. Suitability and Sensitivity of Outcome Measures: Nutrition 1

    Time frame: At baseline, before admission to hospital for surgery and at three month follow up post surgery

    Height (cms) and weight (kg) will be combined to report BMI in kg/m^2

  11. Suitability and Sensitivity of Outcome Measures: Nutrition 2

    Time frame: At baseline, prior to admission for surgery and at three month follow up post surgery

    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.

  12. Suitability and Sensitivity of Outcome Measures: Mental Well-being

    Time frame: At baseline, before admission to hospital for surgery and at three month follow up post surgery

    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.

  13. Suitability and Sensitivity of Outcomes Measures: Smoking

    Time frame: At baseline, preadmission for surgery and three months follow-up post surgery.

    Smoking habits measured using GATS (Global Adult Tobacco Survey) It asks about smoking and smokeless tobacco use, quitting habits and exposure to secondhand smoke.

  14. Suitability and sensitivity of outcome measure: Alcohol Intake

    Time frame: At baseline, preadmission for surgery and at three month follow-up post surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imogen C Fecher-Jones, MSc

CONTACT

[email protected]

+447590270743

Sharon Davies-Dear

CONTACT

[email protected]

+442381205213

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • University Hospital Plymouth NHS Trust
  • University of Southampton

Registry information

Official study title

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

Acronym: GoPREPARE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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