Condition category
Cancer
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
05/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Participation in the NHS Bowel Cancer Screening Programme is low, particularly in people from a lower socioeconomic status. The information materials provided to people can be difficult to understand for people with lower levels of literacy, and may therefore inadvertently discourage participation. This study aims to test a low literacy information booklet to be incorporated within the NHS Bowel Cancer Screening Programme.

Who can participate?
Patients registered at four GP practices, aged 45-59

What does the study involve?
Participants are randomly allocated to be sent either the standard information materials, or the standard materials along with a low literacy information booklet.

What are the possible benefits and risks of participating?
Participants learn about the topic of bowel cancer and bowel cancer screening. There are no risks to taking part in the study.

Where is the study run from?
CRUK & UCL Cancer Trials Centre (UK)

When is the study starting and how long is it expected to run for?
July to September 2012

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Samuel Smith
samuel.smith@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Samuel Smith

ORCID ID

Contact details

CR UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
-
samuel.smith@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12483

Study information

Scientific title

Evaluation of a 'gist-based' information leaflet to be used in the NHS Bowel Cancer Screening Programme: a randomised study

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) at home. Recent data suggests that only 54% of those offered the FOB test choose to do 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 ‘gist-based’ leaflet developed by the research team, on future intentions to use the FOB test. Participants aged 45-59 (who have not yet taken part in the BCSP), will be recruited through GP practices. All participants will be sent the usual BCSP information leaflet 'Bowel Cancer Screening: The Facts', while the intervention group will also receive a ‘gist-based’ leaflet. A questionnaire will ask about the participants’ views (e.g. intention to be screened, comprehension, attitudes, beliefs) on bowel cancer and bowel cancer screening. Answers will be compared between the two groups in order to assess the impact of the ‘gist-based’ leaflet.

Ethics approval

NRES Committee Yorkshire & The Humber - Leeds West, 12/YH/0106; First MREC approval date 07/02/2012

Study design

Randomised; Interventional; Design type: Not specified

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

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

All participants will be sent the usual BCSP information leaflet 'Bowel Cancer Screening: The Facts', while the intervention group will also receive a ‘gist-based’ leaflet.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intention to be screened

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/07/2012

Overall trial end date

24/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Registered with a GP Practice
2. Aged between 45-59, Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 840; UK Sample Size: 840

Participant exclusion criteria

1. Patients whom are unable or do not wish to provide informed consent
2. Patients whom the GP advises should not be approached (e.g. recent diagnosis of cancer or other significant illness, terminally ill, learning disability, already receives regular colonoscopies)
3. Patients who are not able to read English

Recruitment start date

02/07/2012

Recruitment end date

24/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CRUK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o Dave Wilson
Gower Street
London
WC1E 6BT
United Kingdom
-
david.wilson@ucl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research - Programme Grant for Applied Research (PGfAR)

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/25253443

Publication citations

Additional files

Editorial Notes

05/05/2016: Plain English summary and publication reference added.