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Lessons Learned From the Family Gene Toolkit

NCT02154633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

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

BEHAVIORAL

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 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 & Collaborators

Principal Investigators

  • Maria C Katapodi, PhD · Adjunct Associate Professor w/ Tenure

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-08-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02154633 on ClinicalTrials.gov