Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hereditary Breast and Ovarian Cancer
- Sponsor
- Washington University School of Medicine
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Proband-reported cascade testing rates of first-degree relatives
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this research study is to learn how cancer care providers can help their patients communicate the need for genetic testing in families with inherited cancer syndromes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
- •Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
- •Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
- •Over the age of 18
- •Psychological ability and general health that permits completion of study requirements and follow-up
- •Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months
Exclusion Criteria
- •"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria
Outcomes
Primary Outcomes
Proband-reported cascade testing rates of first-degree relatives
Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-For each proband, this testing rate is defined as the number of first-degree relatives tested divided by the number of living first-degree relatives age-appropriate for testing, as determined by family surveys done by the proband. The investigators will calculate mean cascade genetic testing rates for both conditions (Usual Care and FACTT intervention).
Family member-reported cascade testing rates
Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing
Number of primary barriers to genetic testing for family members
Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive
Number of primary barriers to genetic testing for first-degree relatives
Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months)
-The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives