NCT02133703

Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	Print DA	BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
BEHAVIORAL	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2014-05-08
• Last updated: 2022-10-14

Locations

1 site across 1 country: United States