Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics

Not Applicable

Recruiting

• Conditions: Breast Cancer; Colorectal Cancer
• Interventions: Behavioral: Screening Form; Behavioral: Genetic Testing and Counseling

• Registration Number: NCT05694559
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.

Detailed Description

Primary Objectives:

* To identify 300 Black families, at least one individual per family, eligible for genetic testing using our validated simple genetic risk screening tool (GRST) 1, via collaboration with trusted community organizations. For individuals eligible for genetic testing, we will counsel them about genetic testing, including reviewing GRST results, explaining why they are eligible for genetic testing as part of standard-of-care, explaining what this entails, offering on-site or remote genetic testing, and explaining that they will be connected to a genetic counselor if they have a pathogenic mutation (PV) of a variant of unknown significance (VUS), including resources for family cascade genetic testing.

* To provide genetic testing to 150 Black individuals and families and provide genetic counseling and risk reduction resources to individuals with a PV or VUS, including cascade genetic testing for their family members.

Study Timeline

• Study Start: 2022-11-23
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Any participant over 18 years old who self-identifies as Black or African-American and signs an informed consent form, also referred to as the 'Permission to Contact' form, to be part of our study.

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening Form	Screening Form	Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. You will be asked to provide your: * Name and contact information (including your address, phone number, and email) * Demographic information (including your age, race, and ethnicity) * Health insurance status * Annual household income * Personal and family history of cancer, including diagnosis and age at diagnosis
Genetic Testing and Counseling	Genetic Testing and Counseling	Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.

Primary Outcome Measures

Name	Time	Method
genetic risk screening tool (GRST) questionnaire	through study completion; an average of 1 year.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States