Condition category
Cancer
Date applied
12/12/2012
Date assigned
21/03/2013
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Gill Hubbard

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12/5001/09

Study information

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

Study hypothesis

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

NHS Research Scotland (NRS), 22/02/2013, REC ref: 13/NS/0004

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

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.

Participant 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

Recruitment start date

31/07/2013

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing, Midwifery and Health
Inverness
IV3 3JH
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.netscc.ac.uk/hsdr/index.html

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24549168
2015 results in: http://www.pilotfeasibilitystudies.com/content/1/1/15/abstract
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26729381
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27583314

Publication citations

  1. Protocol

    Munro J, Adams R, Campbell A, Campbell S, Donaldson C, Godwin J, Haw S, Kidd L, Lane C, Leslie SJ, Mason H, Mutrie N, O'Carroll R, Taylor C, Treweek S, Watson A, Hubbard G, 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., BMJ Open, 2014, 4, 2, e004684, doi: 10.1136/bmjopen-2013-004684.

  2. Results

    G Hubbard, A Campbell, Z Davies, J Munro, AV Ireland, S Leslie, AJM Watson, S Treweek, Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment, Pilot and Feasibility Studies, 2015, 1, 15 , doi: 10.1186/s40814-015-0009-z.

Additional files

Editorial Notes

02/09/2016: Publication reference added.