Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | May 2005 |
| End Date: | December 2016 |
Telephone-Based Genetic Counseling; An Equivalence Trial
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.
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.
OBJECTIVES:
Primary
- Compare the impact of telephone genetic counseling (TGC) versus standard genetic
counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the
BRCA1/BRCA2 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 BRCA1/BRCA2 testing in women at risk of carrying the
BRCA1/BRCA2 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.
DISEASE CHARACTERISTICS:
- Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of
the following:
- First-degree relative of affected family member with a 50% chance of inheriting
a BRCA1/BRCA2 mutation
- Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance
(parent deceased)
- Obligate gene carrier or affected woman
- Must live within 100 miles of the Lombardi Comprehensive Cancer Center
- No more than 4 weeks since breast or ovarian cancer diagnosis
- No metastatic or inflammatory breast cancer or ovarian cancer
- No stage III breast or ovarian cancer while undergoing concurrent chemotherapy
PATIENT CHARACTERISTICS:
- No psychiatric illness or cognitive disorder that would preclude informed consent
PRIOR CONCURRENT THERAPY:
- No prior genetic counseling or testing for BRCA1 and/or BRCA2
We found this trial at
4
sites
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3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-2110
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
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