Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02154633
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-05-30
Brief Title:
Lessons Learned From the Family Gene Toolkit
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Development of a Family Communication and Decision-support Intervention for Women That Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Female Family Members
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FGT
Brief Summary:
Mutations in the BRCA12 genes are the primary cause of hereditary breastovarian cancer syndrome Genetic testing identifies mutation carriers and enables them to manage their cancer risk ie 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 breastovarian cancer
The project aims to develop a family communication and decision-support intervention to 1 increase family communication about BRCA12 mutations 2 reduce psychological distress associated with these mutations and 3 increase informed decision-making regarding uptake of BRCA12 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
The project aims to develop a family communication and decision-support intervention to 1 increase family communication about BRCA12 mutations 2 reduce psychological distress associated with these mutations and 3 increase informed decision-making regarding uptake of BRCA12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Nurse Faculty Scholar 68039 | OTHER_GRANT | Robert Wood Johnson Foundation | None |