Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Janet Jones
ORCID ID
Contact details
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
j.jones.5@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8451
Study information
Scientific title
Diet and physical activity to prevent recurrence of high risk adenomas: a feasibility study
Acronym
Study hypothesis
Colorectal cancer (cancer of the large bowel) is the third most common cancer and second most common cause of cancer death in the UK. One of the aims of the NHS Bowel Cancer Screening Programme is to detect early stage colorectal cancer and adenoma (pre-cancer) thus improve survival. Most colorectal cancers arise from polyps or adenomas, and high-risk adenomas are the most likely to become cancerous. The recurrence rate for high-risk adenomas is approximately 40% after three years. The recent World Cancer Research Fund report in 2007 concluded there was convincing evidence that high dietary red and processed meat and low levels of physical activity cause colorectal cancer.
The aims of the proposed study is to demonstrate the feasibility of altering the behaviour of patients recently diagnosed with high-risk adenoma. This study is intended to reduce the recurrence of high-risk adenoma and designed to:
1. Reduce consumption of red meat and eliminate processed meat from the diet
2. Increase physical activity levels
The first stage of the proposed study includes qualitative research to assess patients' preferences for feasible interventions aimed to bring about behaviour change, a postal questionnaire survey and a review of published evidence. Results of this stage will be assessed in the second phase to determine the most effective ways of delivering the interventions.
Added 24/03/2011: The first and second phases of the study are now complete. Phase three is a trial with 200 newly diagnosed high-risk adenoma patients.
Please note, as of 24/03/2011 the anticipated end date for this trial has been updated from 30/09/2010 to 31/12/2012 and the target number of participants increased from 250 to 370.
Ethics approval
Black Country Research Ethics Committee approved on the 17th December 2009 (ref: 09/H1202/123)
Study design
Single centre observational prevention cross-sectional study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Prevention
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
Focus Groups/interviews:
We will set up five focus groups (six to eight persons per group). The initial discussion will focus on knowledge and health beliefs about the proposed interventions and the aetiology of CRC. We will explore participants' perceptions of the value of the proposed behavioural changes given the possible health benefits of the interventions. Participants will be encouraged to discuss possible barriers (to behaviour modification and to participation in a randomised controlled trial [RCT]) and what may motivate them to change.
Questionnaires:
To build on the evidence review and qualitative work to determine the most promising ways of delivering these interventions patients will be mailed a questionnaire designed to assess participants' preferences for particular interventions and other issues, including the relative acceptability of the food frequency questionnaire (FFQ) or food diaries as potential data collection tools for part 2. The aim is to identify the methods of delivering the interventions that are acceptble to patients.
Added 24/03/2011:
Behavioural change interventions:
Groups will be asked to either reduce red meat intake and eliminate processed meat, increase physical activity levels, do both or change nothing. Behavioural change, compliance and acceptability will be assessed at six and 12 months. If the results of this study are successful, a future trial would aim to demonstrate that such behaviour change can reduce recurrence of high-risk adenomas.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To assess patientsÂ’ preferences for feasible interventions aimed to bring about behaviour change.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
28/05/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. HRAs: greater than five small adenomas or greater than three with at least one greater than or equal to 1 cm
2. IRAs: 3 - 4 small adenomas or at least one greater than 1 cm
3. Aged 60 - 74 years at diagnosis, either sex
4. Diagnosis of I/HRA within one year of entry to study
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
370 (250 at time of registration)
Participant exclusion criteria
1. Ongoing surveillance for CRC and high risk groups (familial history of CRC, familial adenomatous polyposis, hereditary non-polyposis CRC)
2. Any known contraindication to exercise
3. Current cancer treatment
4. Individuals who are vegetarian (greater than 3 months)
5. Individuals who are highly physically active (those meeting the current public health guidelines of 30 minutes of exercise 5 times per week)
6. Those who are both vegetarian and highly physically active (meeting criteria of 4 and 5 above)
7. Diagnosis of I/HRA greater than one year prior to entry to study
Recruitment start date
28/05/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Department of Primary Care and General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16026)
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
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22708848
Publication citations
-
Results
Dowswell G, Ryan A, Taylor A, Daley A, Freemantle N, Brookes M, Jones J, Haslop R, Grimmett C, Cheng KK, Sue W, , Designing an intervention to help people with colorectal adenomas reduce their intake of red and processed meat and increase their levels of physical activity: a qualitative study., BMC Cancer, 2012, 12, 255, doi: 10.1186/1471-2407-12-255.