Title: SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery (Acronym: PREPARE-ABC)
Funder: Department of Health and Social Care

Abstract: Design: A Multi-centre randomised controlled trial recruiting cancer patients awaiting curative colorectal cancer surgery from colorectal UK units. Patients will be randomized to: standard care plus pre and post-hospital discharge supervised hospital-based exercise, standard care plus pre and post-hospital discharge supported home-based exercise and standard care alone pre and post-hospital discharge. An internal pilot phase 7-18 months is built into the design to confirm recruitment before progressing to the full study. Setting: Hospital / Community. Target population: NHS patients awaiting a curative elective colorectal resection. Inclusion Criteria: Males and Females 18yrs older with American Society of Anaesthesiologists physical status I-III. Exclusion Criteria: Contraindications to exercise. Health technology being assessed: Pre and post-hospital discharge exercise vs. standard care. Two exercise regimes: supervised hospital-based and supported home-based. Supervised exercise: Pre-operative period - 45 min exercise counseling session followed by a maximum of 12 aerobic interval exercise sessions 3-4 weeks prior to surgery. Post-hospital discharge - monthly supervised "booster" exercise sessions up to 12 months post-randomisation. Supported home-based exercise: Pre-operative period - 45 min exercise counselling session, followed by a home-exercise programme achieving a minimum of 150 min of moderate aerobic exercise per week. Post-hospital discharge - monthly telephone support until 12 months post-randomisation. Twice weekly resistance exercise will be offered to intervention groups. Counselling sessions / patient contact will incorporate behavioural modification methodology. Patients requiring pre-operative chemo-radiotherapy will start exercise post chemo-radiotherapy. Standard care: Other than the patient information leaflet, no other information relating to peri-operative exercise will be offered. Outcomes: Primary: Short term - Post operative morbidity (POM) 30-days measured by the Clavien-Dindo classification. Long term - HR-QoL at 1 year using the Medical Outcomes Study Short-Form Health Questionnaire (SF-36) and EQ-5D-5L. Secondary: Pre operative change in CPET variables following exercise. Post operative: Length of stay, readmission rate, POM at discharge, 90-day post-operative mortality, Psychological Health Status and self-efficacy for exercise. Cost-effectiveness: Health care resource use and QALYs (using EQ-5D-5L and SF36 via SF6D) will be calculated to estimate incremental cost per QALY of exercise compared to standard care. Process Evaluation: To access interventions we will evaluate - Standard care at each unit prior to randomisation, fidelity to intervention and control arms and any contamination across arms and patient’s views and experiences of interventions. Sample size: POM evident in 55% of patients by day 30. To detect a 25% reduction (relative risk 0.75), 90% power, alpha 2.5%, requires 343 in each arm, 3 arms 1029, 10% attrition rate. Total 1146. Average SF 36 score at 1 year is 52 SD 10. To detect a 3 unit difference, 90% Power, alpha 2.5% requires 276 in each arm, 3 arms 828, 20% attrition rate. Total 1035 Project timetable: Months 0-6 regulatory approvals, Months 6-18 pilot phase, Months 19-36 recruitment to full trial, Months 3-48 Follow up, Months 49-50 Completion of data analysis. Expertise in team Multi-disciplinary team with skills to deliver the study.

Lay abstract: Colorectal cancer is the second commonest cancer in the UK affecting 40,000 new patients every year. The best treatment is an operation to remove their cancer. However while an operation offers the best chance of cure it can result in significant complications or patients no longer experiencing the same quality of life as they did before surgery. Patients who do experience complications following a colorectal cancer operation may need to remain in hospital for weeks to months and require an increased level of care while in and out of hospital. This results in a marked reduction in their quality of life and places increased pressure on the them, their families and the NHS. It is recognised that the fitter patients are prior to an operation; the greater the chance they have of recovering without developing a complication, and returning to their normal daily activities. A number of small research studies have shown that patients who start to undertake regular exercise in the short period of time (usually 3 to 4 weeks) they have before between their diagnosis of cancer and their operation can increase their fitness and this may result in improved recovery. After an operation for colorectal cancer it is also recognised that patients who start to exercise recover better in the long term, and can even decrease their chance of developing a relapse of their cancer. Patients, Surgeons, Anaesthetists, Nurses and Exercise specialists have joined together to design a study to determine if exercise, and what type of exercise, before and after surgery for colorectal cancer patients reduces post surgical complications and lead to an improved quality of life in patients undergoing surgery for colorectal cancer. They will recruit patients from hospitals around the UK. Patients will be randomly allocated to receive supervised exercise in hospital; a pre-set programme of exercise at home with telephone support; or the usual care currently offered. The exercise will be performed in the 3 to 4 weeks leading up to surgery and then 6 weeks after surgery for a total of 1 year. The researchers will assess patients at regular interval to determine if any complications occur within 30 days of their surgery and using special questionnaires determine their quality of their life 12 months after starting the study. It is hoped that by using this approach the researchers will be able to produce clear evidence as to the benefits of exercise before and after surgery and determine if this is a cost effective way to reduce complications and improving quality of life in patients undergoing colorectal cancer surgery.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS