University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL6 8DH, United Kingdom
Location status: Recruiting
Location contact
Elinor Pegg
CONTACT
Helen Anderson
CONTACT
Steve Evans
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07278622
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Plymouth, Devon, PL6 8DH, United Kingdom
Location status: Recruiting
Elinor Pegg
CONTACT
Helen Anderson
CONTACT
Steve Evans
PRINCIPAL_INVESTIGATOR
See uploaded protocol
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From start of recruitment to recruitment closing. Approximately 6 months
E.g. number recruited compared with number eligible.
Time frame: During recruitment period approximately 6 months
Number of patients who decline to take part in the study and reasons.
Time frame: From start of trial to recruitment closing. Approximately 6 months
Number of eligible patients not approached and reasons.
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.
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.
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.
Time frame: From recruitment through to three month post surgery follow up. (Approx 4 months total)
Return rate and completeness of questionnaires.
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.
Time frame: From recruitment through to three month post surgery follow up. (Approx 4 months total)
Documentation of adverse events occurring during trial duration
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)
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.
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
Time frame: At baseline for two weeks and at three months post surgery
Number of steps while active using a triaxial accelerometer eg. Actigraph
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
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
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
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Imogen C Fecher-Jones, MSc
CONTACT
Sharon Davies-Dear
CONTACT
University Hospital Southampton NHS Foundation Trust
Other
Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)
Acronym: GoPREPARE
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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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