FGT: Lessons Learned From the Family Gene Toolkit

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02154633
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Actual Duration (Months): 78
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Women With BRCA 1 or BRCA 2 Mutation; Non-tested Female Family Members	Behavioral: Family Gene Toolkit; Behavioral: Delayed Family Gene Toolkit	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Actual Study Start Date: Sep 30, 2010
• Actual Primary Completion Date: Aug 31, 2014
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Intention for genetic testing [1 month post-intervention]

   Intention to have genetic testing

2. Decisional conflict for genetic testing [1 month post-intervention]

   Difficulty deciding about having genetic testing

3. Decisional regret [1 month post-intervention]

   Regret after having genetic testing

Secondary Outcome Measures

1. Knowledge of BRCA1/2 genetics [1 month post-intervention]

   Genetic literacy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Maria C Katapodi, PhD, Adjunct Associate Professor w/ Tenure

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Michigan
• ClinicalTrials.gov Identifier: NCT02154633
• Other Study ID Numbers: RWJ68039; Nurse Faculty Scholar 68039
• First Posted: Jun 3, 2014
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Feb 25, 2020