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 |
| Protocol serial number | 12/5001/09 |
| Sponsor | University of Southampton (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Health Services and Delivery Research Programme (ref: 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
Contact information
Dr Gill Hubbard
Scientific
Scientific
School of Nursing, Midwifery and Health
Centre for Health Science
Old Perth Road
Inverness
IV3 3JH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
Quality of life measures |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 78 |
| 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
- United Kingdom
- Scotland
Study participating centre
School of Nursing, Midwifery and Health
Inverness
IV3 3JH
United Kingdom
IV3 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No | |
| Results article | results | 04/01/2016 | Yes | No | |
| Results article | results | 01/08/2016 | Yes | No | |
| Protocol article | protocol | 18/02/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2016: Publication reference added.
