Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children
Adults who lack mental capacity.
Adults who do not understand spoken English.
Previous experience of prehabilitation.
Trial design
Design model
Parallel
Treatments tested in this trial
GoPREPARE
Other interventionGoPREPARE 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: GoPREPARE Education InterventionExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility Outcome Measure: Proportion of eligible patients recruited
E.g. number recruited compared with number eligible.
Time frame
From start of recruitment to recruitment closing. Approximately 6 months2
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.
Time frame
During recruitment period approximately 6 months3
Feasibility Outcome Measure: Number of missed eligible patients
Number of eligible patients not approached and reasons.
Time frame
From start of trial to recruitment closing. Approximately 6 months4
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.
Time frame
From recruitment through to three month post surgery follow up. (Approx 4 months total)Secondary outcomes
1
Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires
Return rate and completeness of questionnaires.
Time frame
From recruitment through to three month post surgery follow up. (Approx 4 months total)2
Suitability and sensitivity of outcome measures: Average time participants wear their accelerometer
Participant compliance with wearing accelerometer and usefulness of data collected.
Time frame
From recruitment for two weeks, for one further week at around 3 months post surgery.3
Suitability and sensitivity of outcome measures: Adverse events
Documentation of adverse events occurring during trial duration
Time frame
From recruitment through to three month post surgery follow up. (Approx 4 months total)4
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)
Time frame
In hospital stay approx 3-5 weeks following recruitmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Southampton NHS Foundation Trust
Lead sponsor
University Hospital Plymouth NHS Trust
Collaborator
University of Southampton
Collaborator
Source ClinicalTrials.gov