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

ISRCTN	ISRCTN62215021
DOI	https://doi.org/10.1186/ISRCTN62215021
Secondary identifying numbers	12483

Submission date: 22/06/2012
Registration date: 22/06/2012
Last edited: 05/05/2016

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

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

Contact information

Mr Samuel Smith
Scientific

CR UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Email	samuel.smith@ucl.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of a 'gist-based' information leaflet to be used in the NHS Bowel Cancer Screening Programme: a randomised study
Study objectives	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(s)	NRES Committee Yorkshire & The Humber - Leeds West, 12/YH/0106; First MREC approval date 07/02/2012
Health condition(s) or problem(s) studied	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
Primary outcome measure	Intention to be screened
Secondary outcome measures	Not provided at time of registration
Overall study start date	02/07/2012
Completion date	24/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 840; UK Sample Size: 840
Key inclusion criteria	1. Registered with a GP Practice 2. Aged between 45-59, Male & Female
Key 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
Date of first enrolment	02/07/2012
Date of final enrolment	24/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

CRUK & UCL Cancer Trials Centre

London
W1T 4TJ
United Kingdom

Sponsor information

University College London (UK)
University/education

c/o Dave Wilson
Gower Street
London
WC1E 6BT
England
United Kingdom

Email	david.wilson@ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research - Programme Grant for Applied Research (PGfAR)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No

Editorial Notes

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