Telephone-Based Genetic Counseling; An Equivalence Trial
21 Years
85 Years
Female
Breast Cancer
Trial Information
Telephone-Based Genetic Counseling; An Equivalence Trial
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Marc Schwartz, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Lombardi Cancer Research Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000450959
NCT ID:
NCT00287898
Start Date:
May 2005
Completion Date:
December 2015
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
