Feasibility of a personalised, distance-based lifestyle intervention in colorectal cancer patients
| ISRCTN | ISRCTN45454522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45454522 |
| Secondary identifying numbers | 9281 |
- Submission date
- 02/11/2010
- Registration date
- 02/11/2010
- Last edited
- 03/03/2016
- 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 Chloe Grimmett
Scientific
Scientific
Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
| c.grimmett@ucl.ac.uk |
Study information
| Study design | Multicentre non-randomised interventional pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The feasibility of a personalised, distance-based lifestyle intervention in colorectal cancer (CRC) patients who have recently completed treatment, focusing on increasing fruit and vegetable (F&V) intake, reducing red and processed meat consumption, and increasing physical activity |
| Study objectives | This is a pilot study to examine the feasibility and acceptability of a distance-based intervention to increase physical activity and fruit and vegetable consumption and reduce red and processed meat consumption in patients who have recently completed treatment for bowel cancer. |
| Ethics approval(s) | UCLH NHS Foundation Trust Ethics Committee, 14/10/2009, ref: 09/H0715/44 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon, Rectum |
| Intervention | This is a feasibility study without a control group, therefore all participants will receive the same intervention. Participants will be provided with written information regarding the benefits of changes in physical activity, F&V, red and processed meat consumption following bowel cancer. They will then receive 6 personalised telephone consultations over the course of 3 months (1 call every 2 weeks). These sessions, based on self-regulation theory, will take into account baseline levels of each behaviour and introduce goal setting with the aim of gradually improving behaviour and a rate that is sustainable. Participants will also be educated regarding behaviour change skills, such as self-monitoring and evaluation of behavioural goals. Participants will be given logbooks and a pedometer in order to record their behaviour. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility, measured on trial completion |
| Secondary outcome measures | All measured on trial completion: 1. Acceptability 2. Blood samples to measure vitamin C, E and plasma carotene 3. Change in physical activity 4. Fatigue 5. Fruit and vegetable consumption 6. Insulin-like growth factor 1 (IGF-1) 7. Physical function 8. Quality of life (Functional Assessment of Cancer Therapy-Colorectal [FACT-C]) 9. Red and processed meat consumption |
| Overall study start date | 01/04/2011 |
| Completion date | 29/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 30 |
| Key inclusion criteria | 1. Patients within 6 months of treatment completion for M0 colorectal cancer 2. Can speak and read in English 3. Aged over the age of 18 years but with no maximum age limit, either sex |
| Key exclusion criteria | 1. Any contraindications preventing participation in unsupervised physical activity 2. Those who have ileostomy/colostomy bags |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 29/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
England
United Kingdom
| Website | http://www.wcrf.org/ |
|---|---|
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Research organisation
World Cancer Research Fund
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- World Cancer Research Fund UK, WCRF, WCRF UK
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No |
Editorial Notes
03/03/2016: Publication reference added.
