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

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-lifestyle-changes-after-treatment-bowel-cancer

Contact information

Dr Chloe Grimmett
Scientific

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom

Email c.grimmett@ucl.ac.uk

Study information

Study designMulticentre non-randomised interventional pilot study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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 objectivesThis 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) studiedTopic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
InterventionThis 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 typeBehavioural
Primary outcome measureFeasibility, measured on trial completion
Secondary outcome measuresAll 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 date01/04/2011
Completion date29/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 30
Key inclusion criteria1. 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 criteria1. Any contraindications preventing participation in unsupervised physical activity
2. Those who have ileostomy/colostomy bags
Date of first enrolment01/04/2011
Date of final enrolment29/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London
London
WC1E 6BT
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
England
United Kingdom

Website http://www.wcrf.org/
ROR logo "ROR" https://ror.org/042fqyp44

Funders

Funder type

Research organisation

World Cancer Research Fund
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.