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	https://doi.org/10.1186/ISRCTN63510637
Secondary identifying numbers	12/5001/09

Submission date: 12/12/2012
Registration date: 21/03/2013
Last edited: 02/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-exercise-programme-after-bowel-cancer-surgery-crib

Contact information

Dr Gill Hubbard
Scientific

School of Nursing, Midwifery and Health
Centre for Health Science
Old Perth Road
Inverness
IV3 3JH
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study acronym	CRIB
Study objectives	Is existing cardiac rehabilitation service an acceptable model of rehabilitation to aid the recovery of cancer patients? More details can be found at: http://www.nets.nihr.ac.uk/projects/hsdr/12500109 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0019/81217/PRO-12-5001-09.pdf
Ethics approval(s)	NHS Research Scotland (NRS), 22/02/2013, REC ref: 13/NS/0004
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	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.
Intervention type	Other
Primary outcome measure	Physical activity levels using an 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 measures	Quality of life measures
Overall study start date	01/03/2013
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
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.
Key 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
Key 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
Date of first enrolment	31/07/2013
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

School of Nursing, Midwifery and Health

Inverness
IV3 3JH
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Health Services and Delivery Research Programme
National Institute for Health Research
Evaluation, Trials and Studies Coordinating Centre
Alpha House
Southampton
SO16 7NS
England
United Kingdom

Website	http://www.netscc.ac.uk/hsdr/index.html
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Health Services and Delivery Research Programme (ref: 12/5001/09)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/02/2014		Yes	No
Results article	results	01/12/2015		Yes	No
Results article	results	04/01/2016		Yes	No
Results article	results	01/08/2016		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

02/09/2016: Publication reference added.