Lessons Learned From the Family Gene Toolkit (FGT)

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

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.

Study Overview

• Status: Completed
• Conditions: Women With BRCA 1 or BRCA 2 Mutation; Non-tested Female Family Members
• Intervention / Treatment: Behavioral: Family Gene Toolkit; Behavioral: Delayed Family Gene Toolkit

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention for genetic testing	Intention to have genetic testing	1 month post-intervention
Decisional conflict for genetic testing	Difficulty deciding about having genetic testing	1 month post-intervention
Decisional regret	Regret after having genetic testing	1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of BRCA1/2 genetics	Genetic literacy	1 month post-intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Maria C Katapodi, PhD, Adjunct Associate Professor w/ Tenure

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2010
• Primary Completion (ACTUAL): August 31, 2014
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (ESTIMATE): June 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RWJ68039; Nurse Faculty Scholar 68039 (OTHER_GRANT: Robert Wood Johnson Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Request for data, explanation of research question, and time frame