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

The Washington University

Status: Terminated

Conditions: Lynch Syndrome; Hereditary Breast and Ovarian Cancer

Treatments: Other: Families Accelerating Cascade Testing Toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT04508764

202006168

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Usual Care

No Intervention group

Description:

* 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

FACT Toolkit (FACTT)

Experimental group

Description:

* 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

Treatment:

Other: Families Accelerating Cascade Testing Toolkit