Colorectal Cancer ScreeningPhase 2NCT00148226
ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial
A Phase 2 study testing Decision Aid in people with Colorectal Cancer Screening, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteAustralia
- Study dates
- Nov 2003to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poor English, impaired cognition, significant comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening
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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Decision Aid
- Keywords
- Decision Aid, Faecal Occult Blood Test, Colorectal Cancer Screening, Informed Decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startNov 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Lyndal J Trevena, MBBS, Principal investigator, University of SydneyLes Irwig, PhD, Study director, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148226
- Sponsor's protocol ID
- 211205
- Status last verified
- Sep 2005
- First submitted
- 5 Sep 2005
- Last updated
- 4 Jan 2006
- Results posted
- No
Publications
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.
PubMed 18573775
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening
- ClinicalTrials.gov ID
- NCT00148226
- Acronym / sponsor ID
- 211205
- Conditions
- Colorectal Cancer Screening
- Keywords
- Decision Aid, Faecal Occult Blood Test, Colorectal Cancer Screening, Informed Decision-making
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Sep 2005
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Poor English, impaired cognition, significant comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2006.
- Derived from this study: PubMed 18573775Trevena 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndal J Trevena, MBBS principal investigator
University of Sydney
Les Irwig, PhD study director
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decision Aid in people with Colorectal Cancer Screening, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2006.