Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Georgetown University
- Enrollment
- 369
- Locations
- 1
- Primary Endpoint
- Decision Satisfaction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Enhanced Internet DA (Behavioral)
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.
Intervention: Internet DA (Behavioral)
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.
Intervention: Enhanced Print DA (Behavioral)
Mutation Carrier: Print DA
BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.
Intervention: Print DA (Behavioral)
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
Intervention: Inconclusive Results DA (Behavioral)
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
Outcomes
Primary Outcomes
Decision Satisfaction
Time Frame: 12-months post-randomization
Satisfaction with Decision Scale
Psychological Distress
Time Frame: 1-month post randomization
Decision Conflict
Time Frame: 1-month post-randomization
Decisional Conflict Scale
Knowledge
Time Frame: 1-month post randomization
Knowledge of risk management options.
Health Related Quality of Life
Time Frame: 12-months post randomization
SF-12
Utilization of breast and ovarian cancer risk management options
Time Frame: 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 Outcomes
- Knowledge(3-months post randomization)
- Psychological Distress(3-months post-randomization)
- Decisional Conflict(3-months post-randomization)