Non-tested Female Family Members, Women With BRCA 1 or BRCA 2 Mutation
Conditions
Brief summary
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.
Interventions
BEHAVIORALFamily Gene Toolkit
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
BEHAVIORALDelayed Family Gene Toolkit
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
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for mutation carrier: 1. had genetic testing for BRCA 1 or BRCA 2, and received positive test results; 2. are older than 18 years; 3. speak English; 4. agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and 5. have access to an Internet enabled computer. Inclusion Criteria for relatives 1. did not have genetic testing for BRCA 1 or BRCA 2; 2. are older than 18 years; 3. speak English; and 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention for genetic testing | 1 month post-intervention | Intention to have genetic testing |
| Decisional conflict for genetic testing | 1 month post-intervention | Difficulty deciding about having genetic testing |
| Decisional regret | 1 month post-intervention | Regret after having genetic testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of BRCA1/2 genetics | 1 month post-intervention | Genetic literacy |
Countries
United States
Outcome results
None listed