Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287898
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2006-02-06
Brief Title:
Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Telephone-Based Genetic Counseling An Equivalence Trial
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 may work as well over the telephone as it does in-person It is not yet known whether genetic counseling by telephone is more effective than standard in-person genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation
PURPOSE This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard in-person genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation
PURPOSE This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard in-person genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation
Detailed Description:
OBJECTIVES
Primary
Compare the impact of telephone genetic counseling TGC versus standard genetic counseling SGC on utilization of BRCA1BRCA2 testing in women at risk of carrying the BRCA1BRCA2 mutation
Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process informed decision making psychosocial distress and quality of life
Secondary
Identify participant characteristics that predict differential response to TGC
Explore the mechanisms by which TGC or SGC impact distress and quality of life
OUTLINE This is a randomized multicenter study Participants are stratified according to participating site Participants are randomized to 1 of 2 groups
Group 1 standard genetic counseling Participants undergo an in-person genetic counseling session Participants are then given the option of providing blood for genetic testing at the study site Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor
Group 2 telephone-based genetic counseling Participants undergo a telephone-based genetic counseling session Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail Participants receive their results over the phone from their genetic counselor
After completion of genetic counseling all participants are followed periodically for 1 year
PROJECTED ACCRUAL A total of 600 participants will be accrued for this study
Primary
Compare the impact of telephone genetic counseling TGC versus standard genetic counseling SGC on utilization of BRCA1BRCA2 testing in women at risk of carrying the BRCA1BRCA2 mutation
Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process informed decision making psychosocial distress and quality of life
Secondary
Identify participant characteristics that predict differential response to TGC
Explore the mechanisms by which TGC or SGC impact distress and quality of life
OUTLINE This is a randomized multicenter study Participants are stratified according to participating site Participants are randomized to 1 of 2 groups
Group 1 standard genetic counseling Participants undergo an in-person genetic counseling session Participants are then given the option of providing blood for genetic testing at the study site Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor
Group 2 telephone-based genetic counseling Participants undergo a telephone-based genetic counseling session Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail Participants receive their results over the phone from their genetic counselor
After completion of genetic counseling all participants are followed periodically for 1 year
PROJECTED ACCRUAL A total of 600 participants 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-2004-133 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |
| R01CA082346 | NIH | None | None |
| R01CA108933 | NIH | None | None |
| P30CA051008 | NIH | None | None |