Title: The use of cardiac rehabilitation services to aid the recovery of colorectal cancer patients: A pilot randomised controlled trial with embedded feasibility study
Funder: Chief Scientist Office (Scotland)

Abstract: AIMThe aim of the research is to assess whether using an existing cardiac rehabilitation service an acceptable model of rehabilitation to aid the recovery of cancer patients?PHASE 1: FEASIBILITY STUDY OBJECTIVES1. To assess the feasibility of delivering rehabilitation to cancer patients within a cardiac rehabilitation setting.2. To assess the acceptability of the intervention for patients and clinicians (cancer and cardiac).3. To assess the acceptability and adequacy of the training and support provided by a cancer-exercise specialist for cardiac physiotherapists running the rehabilitation exercise classes. 4. To assess the feasibility and acceptability of the main trial components (e.g. recruitment procedures rehabilitation referral procedures and proposed outcomes and process measurement tools) and proposed tools for measuring impacts on outcomes and costs.PHASE 2: PILOT STUDY OBJECTIVES5. To determine eligibility consent recruitment and retention rates and speed of recruitment.6. To determine likely contamination across trial arms7. To determine completion rates for proposed effect outcomes measurement tools at baseline and follow up.8. To provide data for sample size calculations for a definitive RCT.9. To assess intervention fidelity according to study protocol.10. To assess the extent to which intervention and trial procedures can be integrated into routine clinical practice.11. To conduct a preliminary economic evaluation of the cancer rehabilitation programme.DESIGN This is a two-arm pilot RCT with embedded feasibility study that will be undertaken as a phased programme of work comprising of intervention testing and feasibility work (Phase 1) and a pilot trial with a process evaluation (Phase 2). SAMPLEThe sample size in Phase 1 is 12 cancer patients 6 cardiac patients and 6 clinicians. In Phase 2 the estimated sample size is 66 colorectal cancer patients.CANCER PATIENT ELIGIBILITYAdults who have been i) diagnosed with primary colorectal cancer and ii) are in the recovery period following surgery; and may or may not be receiving adjuvant chemotherapy.EXCLUSION CRITERIAAdults who: i) have advanced disease; or ii) fail clinical/risk assessment for rehabilitation and therefore deemed by clinicians as unsafe to participate in exercise classes; or iii) have a severe cognitive impairment and are therefore unable to give informed consent to participate in the study; or iv) are unable to communicate in English.INTERVENTION The intervention is rehabilitation for colorectal cancer patients in a cardiac rehabilitation setting delivered by a member of the cardiac multi-disciplinary team to a mixed class of cancer/cardiac patients with some components specifically tailored for cancer patients and delivered by a cancer nurse. PROPOSED OUTCOME MEASURESPrimary outcome: Physical activity - IPAQ and accelerometer; Secondary outcomes: Quality of life - EQ-5D & SF-36; Fatigue - FACT-F; Anxiety and depression – HADS.DATA COLLECTIONPHASE 1: Cardiac rehabilitation physiotherapists will firstly attend one-day training by a cancer-exercise specialist and complete an evaluation form about the training. Then in 1 research site 12 cancer patients will be screened recruited referred for rehabilitation have proposed outcomes measured (i.e. instruments we aim to use to measure effect in a larger scale trial) and attend a weekly rehabilitation programme in a cardiac rehabilitation setting. A screening and recruitment log will be completed by a researcher to document all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given. A researcher will also complete an intervention log to document the number of exercise classes attended by participants type and duration of exercises and which education classes the patient attended. On completion of rehabilitation semi-structured face-to-face interviews will be conducted with i) 12 cancer patients & nominated family member ii) 6 cancer and 6 cardiac clinicians who were involved in screening recruitment referral and/or delivering the intervention and iii) 6 cardiac patients involved in the mixed cancer/cardiac patient rehabilitation classes in order to gather responses about the acceptability of the intervention and trial procedures. PHASE 2: In 3 research sites cancer patients will be screened recruited have proposed outcomes measured (i.e. instruments we aim to use to measure effect in a larger scale trial) and then randomised to the intervention or control group. Those randomised to the intervention group will be referred for rehabilitation and attend rehabilitation classes in a cardiac rehabilitation setting. Those randomised to the control group will receive ‘Staying healthy after bowel cancer’ booklet by Bowel Cancer UK which includes a section on Staying Fit. A screening and recruitment log will be completed by a researcher to document all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given. A researcher will also complete an intervention record log to assess intervention fidelity. On completion of rehabilitation participants will again complete the outcome measures. In addition semi-structured face-to-face interviews will be conducted with 24 cancer patients (4 from each research site/trial arm combination) to gather responses about acceptability of the intervention and trial procedures. COST EVALUATION (Objective 11)Data will be collected on resource use and costs incurred to inform data collection methods for a larger scale trial and also in combination with EQ-5D data initial modelling of the cost per QALY gained by the intervention.ANALYSISAll qualitative data will be analysed in order to address Objectives 1 to 4 and 10. From quantitative data we will generate the following: estimates of eligibility consent recruitment and retention rates and speed of recruitment (Objective 5); estimates of completion rates of study assessment tools (Objective 7); estimates of contamination between intervention and control groups (Objective 6); estimates of intervention fidelity (Objective 9). Descriptive statistics of the outcomes will also be made to inform a sample size calculation for a large-scale trial and decisions as to whether their inclusion would be informative in a future trial (Objective 8).


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR