Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Ovarian Cancer

Intervention / Treatment
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* Behavioral: Enhanced Internet DA
* Behavioral: Internet DA
* Behavioral: Enhanced Print DA
* Behavioral: Print DA
* Behavioral: Inconclusive Results DA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mutation Carrier: Enhanced Internet DA<br>BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. | Behavioral: Enhanced Internet DA<br>* 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.<br>|
| Experimental: Mutation Carrier: Internet DA<br>BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool. | Behavioral: Internet DA<br>* 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.<br>|
| Active Comparator: Mutation Carrier: Enhanced Print DA<br>BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool. | Behavioral: Enhanced Print DA<br>* 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.<br>|
| Active Comparator: Mutation Carrier: Print DA<br>BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool. | Behavioral: Print DA<br>* BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.<br>|
| Experimental: Inconclusive Results: DA<br>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 | Behavioral: Inconclusive Results DA<br>* 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.<br>|
| No Intervention: Inconclusive Results: Usual care<br>Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Knowledge of risk management options. | 1-month post randomization | 
| Decision Conflict | Decisional Conflict Scale | 1-month post-randomization | 
| Decision Satisfaction | Satisfaction with Decision Scale | 12-months post-randomization | 
| Psychological Distress |  | 1-month post randomization | 
| Health Related Quality of Life | SF-12 | 12-months post randomization | 
| Utilization of breast and ovarian cancer risk management options | We will assess uptake of the following risk management strategies: Risk reducing surgery (mastectomy and oophorectomy) Chemoprevention Breast and ovarian cancer screening | 12-months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Knowledge of risk management options | 3-months post randomization | 
| Psychological Distress |  | 3-months post-randomization | 
| Decisional Conflict | Decisional Conflict Scale | 3-months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer