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Genetic Counseling in African American Women

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ClinicalTrials.gov Identifier: NCT00419510
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by:
University of Pennsylvania

January 4, 2007
January 8, 2007
August 17, 2016
February 2003
September 2012   (Final data collection date for primary outcome measure)
  • Psychological functioning
  • Cancer screening behaviors
  • Cancer risk reduction behaviors
Same as current
Complete list of historical versions of study NCT00419510 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Breast Cancer
  • Ovarian Cancer
Behavioral: Culturally Tailored Genetic Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
360
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 85 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00419510
704355
DAMD17-00-1-0262
Not Provided
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Not Provided
University of Pennsylvania
United States Department of Defense
Principal Investigator: Chanita Hughes-Halbert, Ph.D. University of Pennsylvania
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP