Genetic Counseling in African American Women

Breast Cancer Clinical Trial

Official title:

Genetic Counseling for Breast Cancer Susceptibility in African American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419510
• Other study ID #: 704355
• Secondary ID: DAMD17-00-1-0262
• Status: Completed
• Phase: N/A
• First received: January 4, 2007
• Last updated: August 15, 2016
• Start date: February 2003
• Est. completion date: September 2012

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Ovarian Cancer

Intervention

Behavioral:
• Culturally Tailored Genetic Counseling

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological functioning
Primary	Cancer screening behaviors
Primary	Cancer risk reduction behaviors