Genetic Counseling in African American Women
Condition: Breast Cancer; Ovarian Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The objectives of this study are to develop a Culturally Tailored Genetic (CTGC) protocol for
      African American women and evaluate its impact on decision making and satisfaction about
      BRCA1/2 testing, quality of life, and cancer control practices compared to Standard Genetic
      Counseling (SGC). A secondary objective of this study is to identify African American women
      who are most and least likely to benefit from CTGC vs. SGC.
    

Detailed description: 
      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 strategies.

      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.
    

Intervention name(s): Culturally Tailored Genetic Counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Genetic counseling; BRCA1 and BRCA2; African American