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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
Department of Defense |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00419510 |
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: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment |
| Official Title: | Genetic Counseling for Breast Cancer Susceptibility in African American Women |
| 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.
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:
Exclusion Criteria:
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
| Study ID Numbers: | 704355, DAMD17-00-1-0262 |
| Study First Received: | January 4, 2007 |
| Last Updated: | March 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00419510 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Genetic counseling BRCA1 and BRCA2 African American |
|
Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Breast Diseases Endocrine Gland Neoplasms |