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Genetic Counseling in African American Women

This study is currently recruiting participants.
Study NCT00419510.   Last updated on March 21, 2007.   Information provided by University of Pennsylvania

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Descriptive Information Fields
Brief Title  Genetic Counseling in African American Women
Official Title  Genetic Counseling for Breast Cancer Susceptibility in African American Women
Brief 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.

Study Phase
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment
Primary Outcome Measure  Psychological functioning
Cancer screening behaviors
Cancer risk reduction behaviors
Secondary Outcome Measure 
Condition  Breast Cancer
Ovarian Cancer
Intervention  Behavioral: Culturally Tailored Genetic Counseling
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  360
Start Date  February 2003
Completion Date August 2007
Eligibility Criteria 

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
Gender Female
Ages 18 Years to 85 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Chanita Hughes-Halbert, Ph.D.     215-746-7144     chanita@mail.med.upenn.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00419510
Organization ID 704355
Secondary IDs †† DAMD17-00-1-0262
Study Sponsor  University of Pennsylvania
Collaborators †† Department of Defense
Investigators 
Principal Investigator:     Chanita Hughes-Halbert, Ph.D.     University of Pennsylvania    
Information Provided By University of Pennsylvania
Verification Date March 2007
First Received Date  January 4, 2007
Last Updated Date March 21, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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