Cancer SurgeryGoPREPARENCT07278622
Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial
A study testing GoPREPARE in people with Cancer Surgery and Elective Surgery, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Surgery, Elective Surgery, Patient Education
- What is being tested?
- GoPREPARE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children
- Adults who lack mental capacity.
- Adults who do not understand spoken English.
- Previous experience of prehabilitation.
- Previous surgery for cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL6 8DH
Elinor Pegg, 07590270743, elinor.pegg1@nhs.net
Helen Anderson, 07590270743, Helen.anderson12@nhs.net
About this study
Official title: 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.
Read the detailed description
See uploaded protocol
- Conditions
- Cancer Surgery, Elective Surgery, Patient Education, Prehabilitation
- Being tested
- GoPREPARE
- Keywords
- surgery school, prehabilitation, patient education, perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoPREPAREOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GoPREPARE |
| Standard Care | No intervention | Patients will be given a standard prehabilitation leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcome Measure: Proportion of eligible patients recruited
E.g. number recruited compared with number eligible.
Measured: 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.
Measured: During recruitment period approximately 6 months
Feasibility Outcome Measure: Number of missed eligible patients
Number of eligible patients not approached and reasons.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At end of recruitment period. Approximately months 6-8
Secondary outcomes (14)
Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires
Return rate and completeness of questionnaires.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, preadmission for surgery and at three month follow-up post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start2 Sep 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus standard care
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Denny Z Levett, PhD, Study director, Universal Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278622
- Sponsor's protocol ID
- RHM CRI0467
- Acronym
- GoPREPARE
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)
- ClinicalTrials.gov ID
- NCT07278622
- Acronym / sponsor ID
- GoPREPARE / RHM CRI0467
- Conditions
- Cancer Surgery, Elective Surgery, Patient Education, Prehabilitation
- Keywords
- surgery school, prehabilitation, patient education, perioperative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust, University of Southampton
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See uploaded protocol
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention versus standard care
| Arm | Type | Receives |
|---|---|---|
| GoPREPARE Education Intervention | Experimental | Other: GoPREPAREA 1.5 live education webinar delivered to groups of patients and their carers before surgery. Delivered by health care professionals. |
| Standard Care | No intervention | –Patients will be given a standard prehabilitation leaflet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Children
- Adults who lack mental capacity.
- Adults who do not understand spoken English.
- Previous experience of prehabilitation.
- Previous surgery for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoPREPAREGoPREPARE 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. | Other | GoPREPARE Education Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
14 secondary outcomes
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)
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.
Suitability and sensitivity of outcome measures: Adverse events
Time frame: 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
Time frame: In hospital stay approx 3-5 weeks following recruitment
Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality
Time frame: From discharge from hospital to three month follow up
Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance
Time frame: First three days after having had surgery
Suitability and sensitivity of outcome measures: Physical Activity 1
Time frame: At baseline for two weeks and at three months post surgery
Suitability and Sensitivity of Outcome Measures: Physical Activity 2
Time frame: At baseline, prior to admission for surgery and at 3 months post surgery
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.
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
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
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
Suitability and Sensitivity of Outcomes Measures: Smoking
Time frame: At baseline, preadmission for surgery and three months follow-up post surgery.
Suitability and sensitivity of outcome measure: Alcohol Intake
Time frame: At baseline, preadmission for surgery and at three month follow-up post surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denny Z Levett, PhD study director
Universal Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoPREPARE in people with Cancer Surgery and Elective Surgery, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imogen C Fecher-Jones, MSc (+447590270743, Imogen.fecher@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcome Measure: Proportion of eligible patients recruited (time frame: From start of recruitment to recruitment closing. Approximately 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.