Lessons Learned From the Family Gene Toolkit

Not Applicable

Completed

• Conditions: Non-tested Female Family Members; Women With BRCA 1 or BRCA 2 Mutation
• Interventions: Behavioral: Family Gene Toolkit; Behavioral: Delayed Family Gene Toolkit

• Registration Number: NCT02154633
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2014-08-31
• Study Completion: 2017-03-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Family Gene Toolkit	Family Gene Toolkit	Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes
Delayed Family Gene Toolkit	Delayed Family Gene Toolkit	Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes

Primary Outcome Measures

Name	Time	Method
Intention for genetic testing	1 month post-intervention	Intention to have genetic testing
Decisional regret	1 month post-intervention	Regret after having genetic testing
Decisional conflict for genetic testing	1 month post-intervention	Difficulty deciding about having genetic testing

Secondary Outcome Measures

Name	Time	Method
Knowledge of BRCA1/2 genetics	1 month post-intervention	Genetic literacy

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States