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

Lynch Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04508764
• Other study ID #: 202006168
• Status: Terminated
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Lynch Syndrome
• Ovarian Neoplasms
• Syndrome

Intervention

Other:
• Families 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine