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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00148226




Registration number
NCT00148226
Ethics application status
Date submitted
5/09/2005
Date registered
7/09/2005
Date last updated
4/01/2006

Titles & IDs
Public title
ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial
Scientific title
Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening
Secondary ID [1] 0 0
211205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer Screening 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Decision Aid

Behaviour: Decision Aid
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Poor English, impaired cognition, significant comorbidity

Study design
Purpose of the study
Educational/counselling/training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00148226
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lyndal J Trevena, MBBS
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries