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

Not Applicable

Terminated

• Conditions: Hereditary Breast and Ovarian Cancer; Lynch Syndrome
• Interventions: Other: Families Accelerating Cascade Testing Toolkit

• Registration Number: NCT04508764
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2021-04-09
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 96

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

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Exclusion Criteria

-"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
FACT Toolkit (FACTT)	Families Accelerating Cascade Testing Toolkit	* 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

Primary Outcome Measures

Name	Time	Method
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).
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
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States