Lessons Learned From the Family Gene Toolkit

Study Overview
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Brief Summary
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Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer. The project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.

Official Title
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Development of a Family Communication and Decision-support Intervention for Women That Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Female Family Members

Conditions
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Non-tested Female Family Members, Women With BRCA 1 or BRCA 2 Mutation

Intervention / Treatment
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* Behavioral: Family Gene Toolkit
* Behavioral: Delayed Family Gene Toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for mutation carrier: had genetic testing for BRCA 1 or BRCA 2, and received positive test results; are older than 18 years; speak English; agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and have access to an Internet enabled computer. Inclusion Criteria for relatives did not have genetic testing for BRCA 1 or BRCA 2; are older than 18 years; speak English; and have access to an Internet enabled computer. Exclusion Criteria: Women who have no female relatives Women who are unable to consent Women who do not have access to the Internet or the computer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Gene Toolkit<br>Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes | Behavioral: Family Gene Toolkit<br>* Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention<br>|
| Active Comparator: Delayed Family Gene Toolkit<br>Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes | Behavioral: Delayed Family Gene Toolkit<br>* Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention for genetic testing | Intention to have genetic testing | 1 month post-intervention | 
| Decisional conflict for genetic testing | Difficulty deciding about having genetic testing | 1 month post-intervention | 
| Decisional regret | Regret after having genetic testing | 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of BRCA1/2 genetics | Genetic literacy | 1 month post-intervention |