ISRCTN ISRCTN03320951
DOI https://doi.org/10.1186/ISRCTN03320951
Secondary identifying numbers 8451
Submission date
24/06/2010
Registration date
24/06/2010
Last edited
24/01/2022
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-people-pre-cancerous-bowel-growths

Contact information

Mrs Janet Jones
Scientific

Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email j.jones.5@bham.ac.uk

Study information

Study designSingle centre observational prevention cross-sectional study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDiet and physical activity to prevent recurrence of high risk adenomas: a feasibility study
Study objectivesColorectal 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(s)Black Country Research Ethics Committee approved on the 17th December 2009 (ref: 09/H1202/123)
Health condition(s) or problem(s) studiedTopic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
InterventionFocus 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 typeOther
Primary outcome measureTo assess patientsÂ’ preferences for feasible interventions aimed to bring about behaviour change.
Secondary outcome measuresNo secondary outcome measures
Overall study start date28/05/2010
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants370 (250 at time of registration)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment28/05/2010
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Department of Primary Care and General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website http://www.bham.ac.uk/
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16026)

No information available

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 planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/06/2012 Yes No
Plain English results 24/01/2022 No Yes

Editorial Notes

24/01/2022: A link to plain English results was added.