Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416754
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2006-12-27
Brief Title:
Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Improving the Long-Term Outcomes of BRCA1BRCA2 Mutation Testing
Status:
COMPLETED
Status Verified Date:
2017-02
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:
None
Brief Summary:
RATIONALE Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment
PURPOSE This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations
PURPOSE This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations
Detailed Description:
OBJECTIVES
Evaluate the impact of BRCA1BRCA2 testing among members of hereditary breast-ovarian cancer families
Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes
Evaluate the relative impact of standard genetic counseling SGC versus SGC plus the interactive decision-aid IDA on medical decision-making
Evaluate the relative impact of SGC vs SGC IDA on psychological well-being
Explore the mechanisms by which the SGC IDA intervention impacts on psychosocial and behavioral outcomes
OUTLINE This is a multicenter study
Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 15-2 hours that includes information about BRCA12 testing Patients are then offered BRCA12 testing and the test results ie mutation carrier vs noncarrier are presented at a subsequent in-person individual genetic counseling session over 15-2 hours Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms All other patients proceed to follow up
Arm I standard genetic counseling No further counselor-initiated contact is scheduled
Arm II individualized decision aid Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk
Outcome assessments including quality of life assessment are conducted at 2 6 and 12 months
PROJECTED ACCRUAL A total of 950 patients will be accrued for this study
Evaluate the impact of BRCA1BRCA2 testing among members of hereditary breast-ovarian cancer families
Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes
Evaluate the relative impact of standard genetic counseling SGC versus SGC plus the interactive decision-aid IDA on medical decision-making
Evaluate the relative impact of SGC vs SGC IDA on psychological well-being
Explore the mechanisms by which the SGC IDA intervention impacts on psychosocial and behavioral outcomes
OUTLINE This is a multicenter study
Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 15-2 hours that includes information about BRCA12 testing Patients are then offered BRCA12 testing and the test results ie mutation carrier vs noncarrier are presented at a subsequent in-person individual genetic counseling session over 15-2 hours Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms All other patients proceed to follow up
Arm I standard genetic counseling No further counselor-initiated contact is scheduled
Arm II individualized decision aid Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk
Outcome assessments including quality of life assessment are conducted at 2 6 and 12 months
PROJECTED ACCRUAL A total of 950 patients will be accrued for this study
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 |
|---|---|---|---|
| GUMC-2000-305 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |
| P30CA051008 | NIH | None | None |
| R01CA082346 | NIH | None | None |