Lessons Learned From the Family Gene Toolkit

NCT02154633 | Completed DMC

• 2 other identifiers: RWJ68039Nurse Faculty Scholar 68039
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Knowledge of BRCA1/2 genetics

  1 month post-intervention

Study Arms (2)

Family Gene Toolkit

EXPERIMENTAL

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

Delayed Family Gene Toolkit

ACTIVE COMPARATOR

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

Interventions

Family Gene Toolkit BEHAVIORAL

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

Family Gene Toolkit

Delayed Family Gene Toolkit BEHAVIORAL

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

Delayed Family Gene Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had genetic testing for BRCA 1 or BRCA 2, and received positive test results;
• are older than 18 years;
• speak English;
• agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and
• have access to an Internet enabled computer.
• did not have genetic testing for BRCA 1 or BRCA 2;
• are older than 18 years;
• speak English; and
• have access to an Internet enabled computer.

You may not qualify if:

• Women who have no female relatives
• Women who are unable to consent
• Women who do not have access to the Internet or the computer

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 29653920 RESULT

Study Officials

• Maria C Katapodi, PhD

  Adjunct Associate Professor w/ Tenure

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: September 30, 2010
• Primary Completion: August 31, 2014
• Study Completion: March 31, 2017
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)