NCT00419510

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

9.6 years

First QC Date

January 4, 2007

Last Update Submit

August 15, 2016

Conditions

Breast CancerOvarian Cancer

Keywords

Genetic counselingBRCA1 and BRCA2African American

Outcome Measures

Primary Outcomes (3)

  • Psychological functioning

  • Cancer screening behaviors

  • Cancer risk reduction behaviors

Interventions

Culturally Tailored Genetic CounselingBEHAVIORAL

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • African American or Black
  • % to 10% prior probability of having a BRCA1 or BRCA2 mutation

You may not qualify if:

  • Men
  • Individuals who are not African American or Black

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Halbert CH, Kessler L, Collier A, Weathers B, Stopfer J, Domchek S, McDonald JA. Low rates of African American participation in genetic counseling and testing for BRCA1/2 mutations: racial disparities or just a difference? J Genet Couns. 2012 Oct;21(5):676-83. doi: 10.1007/s10897-012-9485-y. Epub 2012 Jul 12.

    PMID: 22790832DERIVED

  • Halbert CH, Kessler L, Troxel AB, Stopfer JE, Domchek S. Effect of genetic counseling and testing for BRCA1 and BRCA2 mutations in African American women: a randomized trial. Public Health Genomics. 2010;13(7-8):440-8. doi: 10.1159/000293990. Epub 2010 Mar 17.

    PMID: 20234119DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsFanconi Anemia, Complementation Group D1

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Chanita Hughes-Halbert, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

February 1, 2003

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)