Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Chloe Grimmett
ORCID ID
Contact details
Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
-
c.grimmett@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9281
Study information
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
Acronym
Study hypothesis
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
UCLH NHS Foundation Trust Ethics Committee, 14/10/2009, ref: 09/H0715/44
Study design
Multicentre non-randomised interventional pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/04/2011
Overall trial end date
29/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30
Participant exclusion criteria
1. Any contraindications preventing participation in unsupervised physical activity
2. Those who have ileostomy/colostomy bags
Recruitment start date
01/04/2011
Recruitment end date
29/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
World Cancer Research Fund
Alternative name(s)
World Cancer Research Fund UK, WCRF, WCRF UK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25245710