Title: The development and pilot trial of two programmes of rehabilitation for cancer patients - ‘PRO REHAB’
Funder: Department of Health (England)

Abstract: Cancer rehabilitation aims to “improve the patient’s quality of life by maximising their ability to function, to promote their independence and to help them to adapt to their condition” (NCHSPCS, 2000). It aims to improve quality of life, no matter how long or short the timescale (NICE, 2004). A recent extensive evidence review of cancer rehabilitation concluded, ‘more primary research is required to investigate the effectiveness of clinically important interventions’ (NCAT, 2012). PRO REHAB aims to directly address this by adapting existing information about cancer rehabilitation (NCAT, 2012) and standards and core components of cardiovascular rehabilitation (BACPR, 2012) to develop two programmes of rehabilitation to meet the needs of patients with breast, colorectal, head and neck, lung and prostate cancers and then to undertake a feasibility study to inform a future fully-powered efficacy trial. The study consists of two linked phases, firstly development and secondly, implementation and assessment of the rehabilitation programmes. Phase I – The existing clinical pathways for this population of patients and rehabilitation experiences of patients and their carers will be assessed in order to describe and document their usual care. Using information gathered from the tumour-specific rehabilitation care pathways (NCAT, 2009), recently updated evidence review (NCAT, 2012) and appropriate guidance from the recent standards and core components for cardiovascular prevention and rehabilitation (BACPR, 2012), cancer-specific rehabilitation interventions will be selected and/or developed by an expert reference group (ERG) of patients, carers and healthcare professionals in order to create two rehabilitation programmes: a) individual, AHP-facilitated home-based and b) multi-disciplinary, group-based programme. People with one of the five cancers who have completed their intensive treatment at one of two centres (Worcestershire Acute Hospitals Trust (WAHT) and UHCW) will be invited to assess a programme. They, their carers and rehabilitation staff will then attend focus group meetings and/or individual interviews to discuss the programme and any changes needed. Based on these discussions, further adaptations to the programmes will be made to best meet the needs of the patient groups. A manual of clinical interventions will be developed in order to standardise practice as much as possible. Phase II - Patients meeting the eligibility criteria as in phase 1 will be invited to participate. Those accepting will be randomised into usual care; individual, AHP-faciliated, home-based rehabilitation; or group-based multidisciplinary rehabilitation, all developed in phase I. The programmes take a maximum of 12 weeks to complete. A sample size of 150 patients (50 patients on each arm) is sufficient to provide reliable estimates of the outcomes and give an indication of the feasibility of an adequately powered trial. Study Outcomes: Phase I Define usual care pathway Creation of individual, AHP faciliated, home-based and multi-disciplinary group-based rehabilitation programmes, acceptable to patients and staff Formation of clinical guidance rehabiliatation manual for staff Phase II Identification and recruitment of patients Fidelity of delivery of interventions Measures at 3 and 6 months: quality of life, physical and psychologocial functioning, concerns, fatigue and health resource use. Recruitment strategies and sample size calculations for a future multi-centre trial Development of a draft patient charter Analysis of Phase II (Pilot Trial) will be performed using appropriate summary measures (means and standard deviations) and 95% confidence intervals for the difference in outcome scores pre and post intervention. In addition, feasibility and acceptability will be assessed among a sample of patients and staff. If the rehabilitation programmes and recruitment are feasible, clinically acceptable and quality of life improvements over time are observed, then an application for funding of a large scale randomised trial of efficacy and cost-effectiveness will be developed.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS