Condition category
Cancer
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
24/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.bham.ac.uk/

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

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22708848

Publication citations

  1. 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.

Additional files

Editorial Notes