Condition category
Cancer
Date applied
05/07/2012
Date assigned
05/07/2012
Last edited
15/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In England, the NHS Bowel Cancer Screening Programme (BCSP) offers screening to over 60 year olds. This involves completing a stool sample test at home. Recent data suggests that only 1 in 2 people who are offered the test, go on to complete it. However, this figure varies from more than 60% in the most socially advantaged groups to less than 35% in the most disadvantaged groups. The aim of this study is to reduce this difference in uptake rates between social groups. This study aims to test the effect of a leaflet by assessing its impact on participantsÂ’ intentions to use the test in a group of adults approaching the age of screening.

Who can participate?
Men and women aged between 45 to 59 and half years, who can read and write English.

What does the study involve?
The study involves sending all potential participants a study pack. The pack contains a covering letter from the participantsÂ’ GP practice, an 8-page questionnaire, a freepost return envelope, and an NHS envelope containing an example of the NHS BCSP invitation letter and a facts booklet about bowel cancer screening. For half of the participants, a narrative leaflet will also be included in the NHS envelope. Participants will be asked to read the contents of the NHS envelope before completing and returning the questionnaire in the freepost envelope to the research team.

What are the possible benefits and risks of participating?
Participants will benefit by learning about an important public health initiative and by contributing to the development of enhanced information materials about the NHS BCSP. There are no known risks of participating in this study.

Where is the study run from?
University College London, UK

When is the study starting and how long is it expected to run for?
June to October 2012

Who is funding the study?
National Institute of Health Research and Cancer Research UK

Who is the main contact?
Dr Lesley McGregor
l.mcgregor@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Mary Thomas

ORCID ID

Contact details

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
-
mary.thomas@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11935

Study information

Scientific title

Assessing the impact of additional patient narrative information on attitudes, beliefs and future intentions to complete the Faecal Occult Blood (FOB) test in adults approaching the age for bowel cancer screening

Acronym

Study hypothesis

Bowel cancer is the second most common cause of cancer death in the UK. Finding cancer early can save lives; therefore, in 2006, the NHS launched a Bowel Cancer Screening Programme (BCSP). In England, the BCSP offers screening to 60-69 year olds (up to 74 years in some areas). Screening involves completing a stool sample test kit (the faecal occult blood test, FOB test) at home. Recent data suggests that only 54% of those offered the FOB test complete it. However, this figure varies from more than 60% in the most socially advantaged groups to less than 35% in the most disadvantaged groups. The current study is part of a larger research programme (the ASCEND Project) funded by the National Institute of Health Research (NIHR) that aims to reduce this difference in uptake rates between social groups. This study specifically aims to assess the influence of a narrative leaflet on future intentions to use the FOB test. The narrative leaflet includes quotes from people who have completed the FOB test. Research has shown that people respond positively to stories of personal experiences when making health related decisions. Participants, aged 45-59 (and who, therefore, have not yet taken part in the BCSP), will be recruited through GP practices. All participants will be sent an example of the usual BCSP invitation pack containing an invitation letter and a facts booklet, with 50% also receiving the narrative leaflet. A questionnaire accompanying the invitation pack will ask about the participant's views on bowel cancer and bowel cancer screening. Participants will be asked to read all the information in the invitation pack before completing the questionnaire. The impact of the narrative leaflet will be assessed by comparing questionnaire responses between the group receiving the usual materials and those receiving the usual materials plus the narrative leaflet.

Ethics approval

NRES Committee North East - Northern and Yorkshire , 15/02/2012, ref: 12/NE/0058

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bowel cancer

Intervention

All participants will receive the usual invitation pack sent by the NHS BCSP. Half of the participants will recieve an additional narrative leaflet.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intention to be screened

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2012

Overall trial end date

21/11/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women registered with one of the GP practices supporting this study
2. Aged between 45-59.5 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 1500

Participant exclusion criteria

1. Patients who have had bowel cancer, a recent diagnosis of cancer or other significant illness, are terminally ill, have a learning disability, already receives regular colonoscopies, or are experiencing cognitive decline
2. GPs will be asked to exclude any patients they believe may become distressed by receiving the questionnaire
3. Patients who are not able to read English. The study involves completing a questionnaire which elicits responses to written materials, and so competancy in English is essential

Recruitment start date

25/07/2012

Recruitment end date

21/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Hampstead Medical Centre
London
-
United Kingdom

Trial participating centre

Morris House Group Practice
London
-
United Kingdom

Trial participating centre

Brunswick House Medical Group
Carlisle
-
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK ref: 148000

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute for Health Research Grant Programme (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25884168

Publication citations

Additional files

Editorial Notes

15/06/2016: Publication reference added.