Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Paul Hewitson

ORCID ID

Contact details

Department of Primary Health Care
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
+44 1865 289445
paul.hewitson@dphpc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6103

Study information

Scientific title

A primary care-based intervention for improvi ng patient participation in bowel cancer screening (pilot study and randomised controlled trial [RCT])

Acronym

Study hypothesis

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

Oxfordshire REC C Committee approved on the 5th June 2009 (ref: 09/H0606/60)

Study design

Multicentre randomised interventional screening trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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: 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

Phase

Phase II/III

Drug names

Primary outcome measures

Participation or not in the NHS BCSP, measured at 3 months

Secondary outcome measures

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.

Overall trial start date

21/09/2009

Overall trial end date

18/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 - 69 years, either sex
2. Invited to the NHS Bowel Cancer Screening Programme

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 1000; UK sample size: 1000

Participant 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)

Recruitment start date

21/09/2009

Recruitment end date

18/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Health Care
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170960/

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.