Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome

Conditions
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Hereditary Breast and Ovarian Cancer, Lynch Syndrome

Intervention / Treatment
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* Other: Families Accelerating Cascade Testing Toolkit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>For approximately the first 6 months of the study, or until 75 patient with cancer who is initially approached in clinic (probands) are enrolled, the investigators will be enrolling probands into the Usual Care group. During this time, the investigators will clarify usual care regarding cascade genetic testing for each participating clinic and proband participant. The investigators will do this by proband participant surveys, as well as initial provider semi-structured interviews. Proband: Complete Cascade Genetic Testing survey. The survey will also contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. At 6 months, there will be a follow-up survey Family Member: Complete survey at study entry and at 6 month follow-up | |
| Experimental: FACT Toolkit (FACTT)<br>Proband: Introduced to FACTT and will complete Cascade Genetic Testing survey. The survey will contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. The probands will also fill out assessments of each FACTT component. At 6 months, there will be a follow-up survey. Family Member: Introduced to FACTT and will complete surveys at study entry and 6 month follow-up. They will also fill out assessments of each FACTT component | Other: Families Accelerating Cascade Testing Toolkit<br>* -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<br>* Other names: FACTT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proband-reported cascade testing rates of first-degree relatives | -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). | From start of study through completion of 6 month follow-up (estimated to be 18 months) | 
| Number of primary barriers to genetic testing for first-degree relatives | -The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives | From start of study through completion of 6 month follow-up (estimated to be 18 months) | 
| Family member-reported cascade testing rates | -This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing | From start of study through completion of 6 month follow-up (estimated to be 18 months) | 
| Number of primary barriers to genetic testing for family members | -The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive | From start of study through completion of 6 month follow-up (estimated to be 18 months) |