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

Washington University School of Medicine96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Hereditary Breast and Ovarian Cancer Lynch Syndrome

Interventions

Families Accelerating Cascade Testing ToolkitOTHER

-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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From start of study through completion of 6 month follow-up (estimated to be 18 months)

Data from ClinicalTrials.gov

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