Genetic Risk Information Disclosure study.
Phase 3
- Conditions
- Genetic mutations predisposing to breast, ovarian or colorectal cancer and methods of disclosing that information to relatives.Cancer - BreastCancer - Ovarian and primary peritonealCancer - Bowel - Back passage (rectum) or large bowel (colon)Human Genetics and Inherited Disorders - Other human genetics and inherited disorders
- Registration Number
- ACTRN12607000316404
- Lead Sponsor
- The Cancer Council Victoria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. A resident of Victoria
2. Current client of a Victorian Familial Cancer Centre
3. The first individual in the family to undertake mutation detection
4. Positive pathogenic mutation detected for breast/ovarian or colorectal cancer
5. Signed informed consent
Exclusion Criteria
1. Prior disclosure of genetic test results
2. Other familal cancer syndromes eg, FAP (Familial Adenomatous Polyposis) or where predictive testing is used in childhood
3. Individuals with pre-existing psychiatric illness or cognitive disorder that would preclude informed consent
4. Individuals not fluent in written or spoken English language
5. Individuals in whom the consent for testing was gained by proxy
6. Another member of an affected family.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of at-risk relatives who contact the FCC for further information[One year after randomisation]
- Secondary Outcome Measures
Name Time Method 1. The number of at-risk relatives attending a FCC for a predictive genetic test.[One year after randomisation.];2. The number of at-risk relatives actively refusing further contact. [One year after randomisation.];3. The number of at risk relatives making a complaint.[One year after randomisation];4. The acceptability of the disclosure process to the proband. [6 weeks after randomisation.];5. The acceptability of the disclosure process to the at risk relative. [12-16 weeks after randomisation.];6. Estimation of any additional costs to the FCC associated with the active disclosure method. [One year after randomisation]