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Telephone-Based Genetic Counseling; An Equivalence Trial

Phase 3
21 Years
85 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Telephone-Based Genetic Counseling; An Equivalence Trial



- 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.


- 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

PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.

Inclusion Criteria


- 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


- No psychiatric illness or cognitive disorder that would preclude informed consent


- No prior genetic counseling or testing for BRCA1 and/or BRCA2

Type of Study:


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:


Principal Investigator

Marc Schwartz, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms



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