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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
369
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Knowledge
Knowledge of risk management options.
Time frame: 1-month post randomization
Decision Conflict
Decisional Conflict Scale
Time frame: 1-month post-randomization
Decision Satisfaction
Satisfaction with Decision Scale
Time frame: 12-months post-randomization
Psychological Distress
Time frame: 1-month post randomization
Health Related Quality of Life
SF-12
Time frame: 12-months post randomization
Utilization of breast and ovarian cancer risk management options
We will assess uptake of the following risk management strategies: 1. Risk reducing surgery (mastectomy and oophorectomy) 2. Chemoprevention 3. Breast and ovarian cancer screening
Time frame: 12-months post-randomization
Knowledge
Knowledge of risk management options
Time frame: 3-months post randomization
Psychological Distress
Time frame: 3-months post-randomization
Decisional Conflict
Decisional Conflict Scale
Time frame: 3-months post-randomization
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