Family Gene Toolkit (FGT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Maria Katapodi, PhD, RN, University of Michigan
ClinicalTrials.gov Identifier:
NCT02154633
First received: May 30, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Women With BRCA 1 or BRCA 2 Mutation
Non-tested Female Family Members
Behavioral: Family Gene Toolkit
Behavioral: Delayed Family Gene Toolkit
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Intention for genetic testing [ Time Frame: 1 month post-intervention ] [ Designated as safety issue: No ]
  • Decisional conflict for genetic testing [ Time Frame: 1 month post-intervention ] [ Designated as safety issue: No ]
  • Decisional regret [ Time Frame: 1 month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge of BRCA1/2 genetics [ Time Frame: 1 month post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2010
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Gene Toolkit
Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes
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
Active Comparator: 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02154633

Contacts
Contact: Maria Katapodi, PhD 734-647-0178 mkatapo@umich.edu
Contact: Kari Mendelsohn-Victor, MPH 734-615-4017 karimend@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kari Mendelsohn-Victor, MPH    734-615-4017    karimend@umich.edu   
Principal Investigator: Maria Katapodi, PhD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Maria Katapodi, PhD, RN, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02154633     History of Changes
Other Study ID Numbers: RWJ68039, Nurse Faculty Scholar 68039
Study First Received: May 30, 2014
Last Updated: May 30, 2014
Health Authority: United States: University of Michigan Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014