Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
NCT ID: NCT02133703
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
369 participants
INTERVENTIONAL
2015-10-31
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Mutation Carrier: Enhanced Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.
Enhanced Internet DA
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.
Mutation Carrier: Internet DA
BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
Internet DA
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.
Mutation Carrier: Enhanced Print DA
BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
Enhanced Print DA
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.
Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
Print DA
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Inconclusive Results: DA
Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making
Inconclusive Results DA
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.
Inconclusive Results: Usual care
Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention
No interventions assigned to this group
Interventions
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Enhanced Internet DA
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.
Internet DA
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.
Enhanced Print DA
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.
Print DA
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
Inconclusive Results DA
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.
Eligibility Criteria
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Inclusion Criteria
* Receive positive or uninformative test results
* English speaking
Exclusion Criteria
* Previous bilateral mastectomy
21 Years
75 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Human Genome Research Institute (NHGRI)
NIH
Georgetown University
OTHER
Responsible Party
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Principal Investigators
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Marc D Schwartz, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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