ICIBS Trial - Improving Patient Information About Bowel C... | NCT00148226

Studies
ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial

NCT00148226

Sponsor

University of Sydney

Status

Completed

Last Update Posted

Jan 4, 2006Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Colorectal Cancer Screening

Interventions

Decision Aid

Countries

Australia

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

Status Module

Record Verification Date

Sep 2005

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

Nov 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Sep 5, 2005

First Submission Date that Met QC Criteria

Sep 5, 2005

First Posted Date

Sep 7, 2005Estimated

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

Jan 3, 2006

Last Update Posted Date

Jan 4, 2006Estimated

Description Module

Brief Summary

This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet.

The decision aid significantly increased the proportion of people who were informed participants in the screening program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Decision Aid	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People aged 50-74 years who were eligible for FOBT screening under current Australian guidelines and had not had screening for colorectal cancer in the preceding two years

Exclusion Criteria:

Poor English, impaired cognition, significant comorbidity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lyndal J Trevena, MBBS	University of Sydney	Principal Investigator
Les Irwig, PhD	University of Sydney	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sydney		Sydney	New South Wales	2006	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18573775	Derived	Trevena LJ, Irwig L, Barratt A. Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008;15(2):76-82. doi: 10.1258/jms.2008.007110.