Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Not Applicable

Completed

• Conditions: Ovarian Cancer; Breast Cancer
• Interventions: Behavioral: Print DA; Behavioral: Inconclusive Results DA; Behavioral: Enhanced Print DA; Behavioral: Internet DA; Behavioral: Enhanced Internet DA

• Registration Number: NCT02133703
• Lead Sponsor: Georgetown University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Study Start: 2015-10
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 369

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mutation Carrier: Print DA	Print DA	BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
Inconclusive Results: DA	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
Mutation Carrier: Enhanced Print DA	Enhanced Print DA	BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.
Mutation Carrier: Internet DA	Internet DA	BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.
Mutation Carrier: Enhanced Internet DA	Enhanced Internet DA	BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.

Primary Outcome Measures

Name	Time	Method
Decision Satisfaction	12-months post-randomization	Satisfaction with Decision Scale
Psychological Distress	1-month post randomization
Decision Conflict	1-month post-randomization	Decisional Conflict Scale
Knowledge	1-month post randomization	Knowledge of risk management options.
Health Related Quality of Life	12-months post randomization	SF-12
Utilization of breast and ovarian cancer risk management options	12-months post-randomization	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

Secondary Outcome Measures

Name	Time	Method
Knowledge	3-months post randomization	Knowledge of risk management options
Psychological Distress	3-months post-randomization
Decisional Conflict	3-months post-randomization	Decisional Conflict Scale

Trial Locations

Locations (1)

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States