Lessons Learned From the Family Gene Toolkit (FGT)

University of Michigan

Status: Completed

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

Treatments: Behavioral: Delayed Family Gene Toolkit; Behavioral: Family Gene Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT02154633

RWJ68039

Nurse Faculty Scholar 68039 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Family Gene Toolkit

Experimental group

Description:

Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes

Treatment:

Behavioral: Family Gene Toolkit

Delayed Family Gene Toolkit

Active Comparator group

Description:

Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes

Treatment:

Behavioral: Delayed Family Gene Toolkit