Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419510
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2007-01-04
Brief Title:
Genetic Counseling in African American Women
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Genetic Counseling for Breast Cancer Susceptibility in African American Women
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BRCA12 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 BRCA12 Genetic counseling and testing for BRCA12 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 BRCA12 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 BRCA12 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 BRCA12 carriers
1 To evaluate the relative impact of CTGC vs SGC on decision making and satisfaction about BRCA12 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 BRCA12 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 BRCA12 carriers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAMD17-00-1-0262 | None | None | None |