Cancer Surgery, Elective Surgery, Patient Education, Prehabilitation
Conditions
Keywords
surgery school, prehabilitation, patient education, perioperative care
Brief 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. 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
Interventions
OTHERGoPREPARE
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.
Sponsors
University Hospital Plymouth NHS Trust
University of Southampton
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention versus standard care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Outcome Measure: Proportion of eligible patients recruited | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Suitability and sensitivity of outcome measures: Physical Activity 1 | At baseline for two weeks and at three months post surgery | Number of steps while active using a triaxial accelerometer eg. Actigraph |
| Suitability and Sensitivity of Outcome Measures: Physical Activity 2 | 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 |
| Suitability and Sensitivity of Outcome Measures: Health Related Quality of Life | 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 |
| Suitability and Sensitivity of Outcome Measures: Nutrition 1 | 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 |
| Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires | From recruitment through to three month post surgery follow up. (Approx 4 months total) | Return rate and completeness of questionnaires. |
| Suitability and Sensitivity of Outcome Measures: Mental Well-being | 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. |
| Suitability and Sensitivity of Outcomes Measures: Smoking | 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. |
| Suitability and sensitivity of outcome measure: Alcohol Intake | 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. |
| Suitability and Sensitivity of Outcome Measures: Nutrition 2 | 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. |
| Suitability and sensitivity of outcome measures: Average time participants wear their accelerometer | 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. |
| Suitability and sensitivity of outcome measures: Adverse events | From recruitment through to three month post surgery follow up. (Approx 4 months total) | Documentation of adverse events occurring during trial duration |
| Suitability and sensitivity of outcome measures: Number of days spent in hospital following surgery | 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) |
| Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality | 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. |
| Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance | 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 |
Countries
United Kingdom
Contacts
Primary ContactImogen C Fecher-Jones, MSc
Backup ContactSharon Davies-Dear
Outcome results
None listed