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CRIB (Cancer Rehabilitation In Bowel cancer): The use of cardiac rehabilitation services to aid the recovery of colorectal cancer patients: A pilot randomised controlled trial (RCT) with embedded feasibility study.
ISRCTN ISRCTN63510637
DOI 10.1186/ISRCTN63510637
ClinicalTrials.gov identifier
EudraCT number
Public title CRIB (Cancer Rehabilitation In Bowel cancer): The use of cardiac rehabilitation services to aid the recovery of colorectal cancer patients: A pilot randomised controlled trial (RCT) with embedded feasibility study.
Scientific title The use of cardiac rehabilitation services to aid the recovery of colorectal cancer patients: A pilot randomised controlled trial (RCT) with embedded feasibility study.
Acronym CRIB
Serial number at source 12/5001/09
Study hypothesis Is existing cardiac rehabilitation service an acceptable model of rehabilitation to aid the recovery of cancer patients?
Lay summary http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-exercise-programme-after-bowel-cancer-surgery-crib
Ethics approval NHS Research Scotland (NRS) approval pending
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Colorectal cancer
Participants - inclusion criteria Adults (male and female) who have been
1. Diagnosed with primary colorectal cancer
2. Are in the recovery period following surgery and may or may not be receiving adjuvant chemotherapy
Participants - exclusion criteria Adults who:
1. Have advanced disease
2. Fail clinical/risk assessment for rehabilitation and therefore deemed by clinicians as unsafe to participate in exercise classes
3. Have a severe cognitive impairment and are therefore unable to give informed consent to participate in the study
4. Are unable to communicate in English
Anticipated start date 01/03/2013
Anticipated end date 31/12/2014
Status of trial Ongoing
Patient information material
Target number of participants The sample size in Phase 1 is 12 cancer patients and their nominated family member, 6 cardiac patients and 12 clinicians. In Phase 2 the estimated sample size is 66 colorectal cancer patients.
Interventions Patients will be randomised to the intervention or control group after they have consented to participating in the study and after baseline primary and secondary measures have been collected. Randomisation with stratification by centre will be conducted by Tayside Clinical Trials Unit.

Participants will either receive rehabilitation (intervention group) or a ‘Staying healthy after bowel cancer’ booklet by Bowel Cancer UK (control group). However, we may make slight modifications to the intervention based on the findings of the feasibility study, which will be documented. To optimise intervention fidelity, interventionists will be expected to follow the cancer patient rehabilitation pathway for this study and their site-specific rehabilitation programme. A researcher will contact participants randomised to the rehabilitation group each week by telephone in order to complete an intervention record log to document for example, type and duration of exercises completed and content of educational classes attended for participants receiving the intervention. A researcher will also contact participants randomised to the control group to record for example, any advice given about exercising.
Primary outcome measure(s) Physical activity levels using accelerometer measured at T0 - before patients are randomised to the intervention or control group, T1 - at the end of the intervention (data will be collected 12 weeks after baseline for patients in the control arm) and T2 - 3 months later.
Secondary outcome measure(s) Quality of life measures
Sources of funding National Institute for Health Research (NIHR) (UK) - Health Services and Delivery Research Programme (Reference number 12/5001/09)
Trial website
Publications 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24549168
Contact name Dr  Gill  Hubbard
  Address School of Nursing, Midwifery and Health
Centre for Health Science
Old Perth Road
  City/town Inverness
  Zip/Postcode IV3 3JH
  Country United Kingdom
Sponsor University of Southampton (UK)
  Address Health Services and Delivery Research Programme
National Institute for Health Research
Evaluation, Trials and Studies Coordinating Centre
Alpha House
  City/town Southampton
  Zip/Postcode SO16 7NS
  Country United Kingdom
  Sponsor website: http://www.netscc.ac.uk/hsdr/index.html
Date applied 12/12/2012
Last edited 08/04/2014
Date ISRCTN assigned 21/03/2013
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