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

Primary Purpose

Colorectal Cancer Screening

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Decision Aid

About this trial

This is an interventional educational/counseling/training trial for Colorectal Cancer Screening focused on measuring Decision Aid, Faecal Occult Blood Test, Colorectal Cancer Screening, Informed Decision-making

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Sydney

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00148226

First Posted

September 5, 2005

Last Updated

January 3, 2006

Sponsor

University of Sydney

1. Study Identification

Unique Protocol Identification Number

NCT00148226

Brief Title

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

Official Title

Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sydney

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Screening

Keywords

Decision Aid, Faecal Occult Blood Test, Colorectal Cancer Screening, Informed Decision-making

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Decision Aid

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lyndal J Trevena, MBBS

Organizational Affiliation

University of Sydney

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Les Irwig, PhD

Organizational Affiliation

University of Sydney

Official's Role

Study Director

Facility Information:

Facility Name

University of Sydney

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2006

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

18573775

Citation

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.

Results Reference

derived

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

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