NCT01250015

Brief Summary

To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening. Design and Intervention. Randomised questionnaire and telephone study comparing the responses of a control group given the standard National Health Service (NHS) CRC screening information with the responses of an intervention group given the same information but enhanced with additional numerical and pictorial information. Setting

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
Last Updated

November 30, 2010

Status Verified

March 1, 2008

Enrollment Period

1 year

First QC Date

November 29, 2010

Last Update Submit

November 29, 2010

Conditions

Keywords

colorectal cancerconsentscreening

Outcome Measures

Primary Outcomes (1)

  • Comparison of the two groups' overall wish to be screened

    The study compared the two groups' overall wish to be screened as recorded by questionnaire

    1 year

Secondary Outcomes (1)

  • Impact of different summary points on subject's desire to be screened

    1 year

Study Arms (2)

control

given standard nhs advice leaflet

interventional

given standard nhs advice leaflet with numerical information and pictograms

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects attending GP and hospital outpatients

You may qualify if:

  • Age 60 - 70

You may not qualify if:

  • No previous cancer or previous colonoscopy Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darlington Memorial Hospital

Darlington, Co Durham, dl3 6hxl, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 30, 2010

Record last verified: 2008-03

Locations