Public perceptions of bowel cancer screening

ISRCTN	ISRCTN84055957
DOI	https://doi.org/10.1186/ISRCTN84055957
Protocol serial number	6103
Sponsor	University of Oxford (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research Capacity Development

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 26/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/trial-looking-what-people-think-information-they-receive-nhs-bowel-cancer-screening-programme

Contact information

Mr Paul Hewitson
Scientific

Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Phone	+44 1865 289445
Email	paul.hewitson@dphpc.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional screening trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A primary care-based intervention for improvi ng patient participation in bowel cancer screening (pilot study and randomised controlled trial [RCT])
Study objectives	The newly established NHS Bowel Cancer Screening Programme (NHS BCSP) offers all eligible men and women aged 60 to 69 a faecal occult blood test (FOBT) every two years in a home-mailed invitation pack. The research trial will evaluate the effectiveness of including a GP endorsement letter and/or a detailed FOBT procedural leaflet in the home-mailed invitation pack for improving participation in the NHS BCSP. The results of the project are anticipated to inform the enhancement of targeted information materials for the NHS BCSP, evaluate the role of primary care for patient choice in bowel cancer screening and directing future research aimed towards improving patient participation in the programme.
Ethics approval(s)	Oxfordshire REC C Committee approved on the 5th June 2009 (ref: 09/H0606/60)
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network, Primary Care Research Network for England; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
Intervention	1. GP endorsement letter 2. Procedural leaflet for completing FOBT Follow up length: 3 months Study entry: multiple randomisations
Intervention type	Other
Primary outcome measure(s)	Participation or not in the NHS BCSP, measured at 3 months
Key secondary outcome measure(s)	1. Knowledge of colorectal cancer (CRC) and screening (10 item scale) 2. Attitudes towards bowel cancer screening Baseline questionnaires sent 6 weeks prior to receiving the invitation to screening; follow-up questionnaires sent 4 weeks after invitation to screening.
Completion date	18/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Total final enrolment	1288
Key inclusion criteria	1. Aged 60 - 69 years, either sex 2. Invited to the NHS Bowel Cancer Screening Programme
Key exclusion criteria	Not eligible for invitation to the NHS Bowel Cancer Screening Programme (i.e. current diagnosis of cancer, people diagnosed with HNPCC or FAP, people currently being treated for bowel conditions)
Date of first enrolment	21/09/2009
Date of final enrolment	18/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Health Care

Oxford
OX3 7LF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
27/11/2015: Publication reference added.