Hereditary Breast and Ovarian Cancer, Lynch Syndrome
Conditions
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.
Interventions
OTHERFamilies Accelerating Cascade Testing Toolkit
-Online family history assessment, video of Siteman Cancer Center genetic counselors, physicians and patients highlighting the importance of cascade genetic testing, reviewing and receiving a family letter and gene information sheet, reviewing websites/online resources, and offering a family visit with a genetic counselor
Sponsors
The Foundation for Barnes-Jewish Hospital
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proband-reported cascade testing rates of first-degree relatives | 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). |
| Number of primary barriers to genetic testing for first-degree relatives | 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 |
| Family member-reported cascade testing rates | 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 | 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 |
Countries
United States
Outcome results
None listed