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Genetic Counseling in African American Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of Pennsylvania.
Recruitment status was  Recruiting
Department of Defense
Information provided by:
University of Pennsylvania Identifier:
First received: January 4, 2007
Last updated: March 21, 2007
Last verified: March 2007
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.

Condition Intervention
Breast Cancer
Ovarian Cancer
Behavioral: Culturally Tailored Genetic Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Genetic Counseling for Breast Cancer Susceptibility in African American Women

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Psychological functioning
  • Cancer screening behaviors
  • Cancer risk reduction behaviors

Estimated Enrollment: 360
Study Start Date: February 2003
Estimated Study Completion Date: August 2007
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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00419510

Contact: Chanita Hughes-Halbert, Ph.D. 215-746-7144

United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Chanita Hughes-Halbert, Ph.D.    215-746-7144   
Sponsors and Collaborators
University of Pennsylvania
Department of Defense
Principal Investigator: Chanita Hughes-Halbert, Ph.D. University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00419510     History of Changes
Other Study ID Numbers: 704355, DAMD17-00-1-0262
Study First Received: January 4, 2007
Last Updated: March 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Genetic counseling
African American processed this record on December 01, 2015