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  • CRIB—the use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial (RCT) with embedded feasibility study

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Rehabilitation medicine
Protocol
CRIB—the use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial (RCT) with embedded feasibility study
  1. Julie Munro1,
  2. Richard Adams2,
  3. Anna Campbell3,
  4. Sandra Campbell4,
  5. Cam Donaldson5,
  6. Jon Godwin5,
  7. Sally Haw1,
  8. Lisa Kidd5,
  9. Chrissie Lane6,
  10. Stephen J Leslie6,
  11. Helen Mason5,
  12. Nanette Mutrie7,
  13. Ronan O'Carroll8,
  14. Cara Taylor9,
  15. Shaun Treweek10,
  16. Angus Watson6,
  17. Gill Hubbard1
  1. 1School of Nursing, Midwifery and Health, University of Stirling, Stirling, UK
  2. 2Cardiff University, School of Medicine, Velindre Hospital, Cardiff, UK
  3. 3Institute of Sport and Exercise, University of Dundee, UK
  4. 4NHS Forth Valley, Larbert, UK
  5. 5School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
  6. 6NHS Highland, Inverness, UK
  7. 7Moray House School of Education, The University of Edinburgh, Edinburgh, UK
  8. 8School of Natural Sciences, University of Stirling, Stirling, UK
  9. 9NHS Tayside, Level 10, Ninewells Hospital, Dundee, UK
  10. 10Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK
  1. Correspondence to Dr Gill Hubbard; gill.hubbard{at}stir.ac.uk

Abstract

Introduction Patients with colorectal cancer report ongoing physical and psychological impairments and a high proportion of these patients are overweight, insufficiently active and high-risk drinkers, putting them at risk of poor recovery and risk of recurrence and comorbidities. A challenge is implementing sustainable and effective rehabilitation as part of routine care for this group.

Methods and analysis A two-arm pilot randomised controlled trial (RCT) with embedded feasibility study undertaken as a phased programme of work. The intervention involves an existing cardiac rehabilitation programme for cardiac patients accepting colorectal cancer patient referrals. The intervention consists of supervised exercise sessions run by a cardiac physiotherapist and information sessions. Phase 1 will involve one research site enrolling 12 patients to assess intervention and study design processes. Semistructured interviews with patients with colorectal cancer and cardiac patients and clinicians will be used to gather data on acceptability of the intervention and study procedures. Phase 2 will involve three sites enrolling 66 patients with colorectal cancer randomised to control or intervention groups. Outcome measures will be taken preintervention and postintervention, for phases 1 and 2. The primary outcome is accelerometer measured physical activity; secondary outcomes are self-report physical activity, quality of life, anxiety, depression, symptoms including fatigue. The following variables will also be examined to determine if these factors influence adherence and outcomes: self-efficacy, risk perception and treatments.

Ethics and dissemination Full ethical approval was granted by NRES Committees—North of Scotland (13/NS/0004; IRAS project ID: 121757) on 22 February 2013. The proposed work is novel in that it aims to test the feasibility and acceptability of using an evidence-based and theory driven existing cardiac rehabilitation service with patients with colorectal cancer. Should this model of rehabilitation prove to be clinically and cost effective we aim to conduct a randomised controlled trial of this intervention to measure effectiveness.

Trial registration reference ISRCTN63510637; UKCRN id 14092.

  • SPORTS MEDICINE
  • REHABILITATION MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

http://dx.doi.org/10.1136/bmjopen-2013-004684

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