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

April 12, 2024 updated by: Washington University School of Medicine
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
  • 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)
  • 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
-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
Other Names:
  • FACTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proband-reported cascade testing rates of first-degree relatives
Time Frame: 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).
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
Time Frame: 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
From start of study through completion of 6 month follow-up (estimated to be 18 months)
Family member-reported cascade testing rates
Time Frame: 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
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
Time Frame: 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
From start of study through completion of 6 month follow-up (estimated to be 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

Investigators

  • Principal Investigator: Andrea Hagemann, M.D., MSCI, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202006168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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