Does Numerical And Pictorial Information On Risk And Bene... | NCT01250015

Studies
Does Numerical And Pictorial Information On Risk And Benefit Affects The Uptake Of Colorectal Cancer Screening?

NCT01250015

Sponsor

County Durham and Darlington NHS Foundation Trust

Status

Completed

Last Update Posted

Nov 30, 2010Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Colorectal Cancer Screening

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CDDFT (UK)	Other Identifier	CDDFT, UK
CDDFT, UK	Other Identifier	CDDFT, UK

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Nov 29, 2010

First Submission Date that Met QC Criteria

Nov 29, 2010

First Posted Date

Nov 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2010

Last Update Posted Date

Nov 30, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

County Durham and Darlington NHS Foundation TrustOTHER_GOV

Collaborators

Name	Class
Internal funding Local Gastroenterology Research fund (Questionnaire only study)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		given standard nhs advice leaflet
interventional		given standard nhs advice leaflet with numerical information and pictograms

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Impact of different summary points on subject's desire to be screened	The impact of each of the 6 summary points in the NHS information leaflet on the subject's desire to be screened depending on whether or not they were enhanced by numerical and pictorial information, the summary point that most influenced their decision on whether to be screened; and the views of the intervention group on the numerical and pictorial information provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 60 - 70

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

healthy subjects attending GP and hospital outpatients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Darlington Memorial Hospital		Darlington	Co Durham	dl3 6hxl	United Kingdom

Label	URL
CDDFT, NHS, UK	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided