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NCT02154633 · ClinicalTrials.gov registry record · NA
Lessons Learned From the Family Gene Toolkit
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT02154633 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 13 participants.
The verdict
NCT02154633, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer. The project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.
Interventions
- BEHAVIORAL Family Gene Toolkit
- BEHAVIORAL Delayed Family Gene Toolkit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09-30 |
| Est. Completion | 2017-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02154633
The ClinicalTrials.gov registry entry for NCT02154633 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Family Gene Toolkit is the first listed.
NCT02154633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02154633 about?
NCT02154633 is a clinical study titled "Lessons Learned From the Family Gene Toolkit". Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing am...
What is the current status of trial NCT02154633?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2010-09-30. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT02154633?
The interventions under investigation include: Family Gene Toolkit (BEHAVIORAL), Delayed Family Gene Toolkit (BEHAVIORAL).
Who is sponsoring clinical trial NCT02154633?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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