Genetic Counseling in African American Women
Recruitment status was Recruiting
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Purpose
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 |
- Psychological functioning
- Cancer screening behaviors
- Cancer risk reduction behaviors
| Estimated Enrollment: | 360 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | August 2007 |
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.
- 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.
- 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.
Eligibility| 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| Contact: Chanita Hughes-Halbert, Ph.D. | 215-746-7144 | chanita@mail.med.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Chanita Hughes-Halbert, Ph.D. 215-746-7144 chanita@mail.med.upenn.edu | |
| 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 ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov 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 BRCA1 and BRCA2 African American |
Additional relevant MeSH terms:
|
Breast Neoplasms Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 19, 2013