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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: Completed NA study, sponsored by University of Michigan.
NCT02154633 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Intention to have genetic testing
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 |
What the finished NCT02154633 record still lists
NCT02154633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Family Gene Toolkit is the first listed.
NCT02154633 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02154633's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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