Clinical trial NCT02154633: Lessons Learned From the Family Gene Toolkit
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With BRCA 1 or BRCA 2 Mutation
Non-tested Female Family Members
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intention for genetic testing
timeFrame: 1 month post-intervention
measure: Decisional conflict for genetic testing
timeFrame: 1 month post-intervention
measure: Decisional regret
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Knowledge of BRCA1/2 genetics
timeFrame: 1 month post-intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Adjunct Associate Professor w/ Tenure
name: Maria C Katapodi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katapodi MC, Jung M, Schafenacker AM, Milliron KJ, Mendelsohn-Victor KE, Merajver SD, Northouse LL. Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study. JMIR Cancer. 2018 Apr 13;4(1):e7. doi: 10.2196/cancer.9210.