ISRCTN ISRCTN84055957
DOI https://doi.org/10.1186/ISRCTN84055957
Secondary identifying numbers 6103
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

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

Study designMulticentre randomised interventional screening trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA primary care-based intervention for improvi ng patient participation in bowel cancer screening (pilot study and randomised controlled trial [RCT])
Study hypothesisThe 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)
ConditionTopic: National Cancer Research Network, Primary Care Research Network for England; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
Intervention1. GP endorsement letter
2. Procedural leaflet for completing FOBT

Follow up length: 3 months
Study entry: multiple randomisations
Intervention typeOther
Primary outcome measureParticipation or not in the NHS BCSP, measured at 3 months
Secondary outcome measures1. 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.
Overall study start date21/09/2009
Overall study end date18/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 1000; UK sample size: 1000
Total final enrolment1288
Participant inclusion criteria1. Aged 60 - 69 years, either sex
2. Invited to the NHS Bowel Cancer Screening Programme
Participant exclusion criteriaNot 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)
Recruitment start date21/09/2009
Recruitment end date18/12/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Health Care
Oxford
OX3 7LF
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

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

Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research Capacity Development

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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
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.