Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Conditions
Breast Cancer - Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Enhanced Internet DA Type: Behavioral
Name: Internet DA Type: Behavioral
Name: Enhanced Print DA Type: Behavioral
Name: Print DA Type: Behavioral
Name: Inconclusive Results DA Type: Behavioral
Overall Status
Not yet recruiting
Summary
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 21 Years
Gender: Female
Criteria: Inclusion Criteria:

- Undergo BRCA1/2 genetic counseling and testing at one of four study sites

- Receive positive or uninformative test results

- English speaking

Exclusion Criteria:

- Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment

- Previous bilateral mastectomy
Location
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States
Status: Not yet recruiting
Contact: Marc D Schwartz, PhD - 202-687-0185 - schwartm@georgetown.edu
Start Date
April 2015
Completion Date
July 2017
Sponsors
Georgetown University
Source
Georgetown University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page