Genetic Counseling in African American Women

Genetic Counseling for Breast Cancer Susceptibility in African American Women

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Ovarian Cancer
• Intervention / Treatment: Behavioral: Culturally Tailored Genetic Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Psychological functioning
Cancer screening behaviors
Cancer risk reduction behaviors

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Chanita Hughes-Halbert, Ph.D., University of Pennsylvania

Publications and helpful links

General Publications

• Halbert CH, Kessler L, Collier A, Weathers B, Stopfer J, Domchek S, McDonald JA. Low rates of African American participation in genetic counseling and testing for BRCA1/2 mutations: racial disparities or just a difference? J Genet Couns. 2012 Oct;21(5):676-83. doi: 10.1007/s10897-012-9485-y. Epub 2012 Jul 12.
• Halbert CH, Kessler L, Troxel AB, Stopfer JE, Domchek S. Effect of genetic counseling and testing for BRCA1 and BRCA2 mutations in African American women: a randomized trial. Public Health Genomics. 2010;13(7-8):440-8. doi: 10.1159/000293990. Epub 2010 Mar 17.

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 4, 2007
• First Submitted That Met QC Criteria: January 5, 2007
• First Posted (Estimate): January 8, 2007

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: African American; BRCA1 and BRCA2; Genetic counseling
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 704355; DAMD17-00-1-0262