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Genetic Counseling for Breast Cancer Susceptibility in African American Women

18 Years
85 Years
Open (Enrolling)
Breast Cancer, Ovarian Cancer

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Trial Information

Genetic Counseling for Breast Cancer Susceptibility in African American Women

Five to 10% of all breast cancer cases have been attributed to two breast ovarian cancer
susceptibility genes called BRCA1 and BRCA2 (BRCA1/2). Genetic counseling and testing for
BRCA1/2 mutations is now available through clinical research programs using standard
counseling protocols. The goal of pre test counseling is to facilitate informed decision
making about whether to be tested and to prepare participants for possible outcomes. The
goal of post test counseling is to provide information about risk status, recommendations
for surveillance, and options for prevention. However, previous research suggests that
African American and Caucasian women differ in their attitudes about and responses to pre
test education and counseling. Increasingly, cultural beliefs and values are being
recognized as important factors in genetic counseling. Despite recommendations to increase
the cultural sensitivity of breast cancer risk counseling, such programs have not been
developed or evaluated. Therefore, the purpose of this study is to develop a Culturally
Tailored Genetic Counseling (CTGC) protocol for African American women and evaluate its
impact on psychological functioning and health behaviors compared with Standard Genetic
Counseling (SGC) in a randomized clinical trial.

1. To evaluate the relative impact of CTGC vs. SGC on decision making and satisfaction
about BRCA1/2 testing. Compared to SGC, CTGC will lead to higher rates of test
acceptance and satisfaction with testing decisions. These effects will be mediated by
increases in perceived benefits and decreases in perceived limitations and risks of
genetic testing.

2. To evaluate the impact of CTGC vs. SGC on quality of life and health behaviors
following BRCA1/2 testing. Compared to SGC, CTGC will lead to larger decreases in
general and cancer specific distress, greater increases in adherence to cancer
screening guidelines, and lower rates of prophylactic surgery. Reductions in
psychological distress will be mediated by increased use of spiritual coping

Secondary Aim

To identify African American women who are most and least likely to benefit from CTGC vs.
SGC. We predict that the relative benefits of CTGC will be greatest for women with greater
endorsement of African American cultural values and those identified as BRCA1/2 carriers.

Inclusion Criteria:

- Female

- African American or Black

- 5% to 10% prior probability of having a BRCA1 or BRCA2 mutation

Exclusion Criteria:

- Men

- Individuals who are not African American or Black

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Psychological functioning

Principal Investigator

Chanita Hughes-Halbert, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

February 2003

Completion Date:

August 2007

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Genetic counseling
  • BRCA1 and BRCA2
  • African American
  • Breast Neoplasms
  • Ovarian Neoplasms



University of Pennsylvania Philadelphia, Pennsylvania  19104