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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05694559

Collaborator

(none)

1,000

Enrollment

Location

Arms

6.2

Anticipated Duration (Months)

160.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Colorectal Cancer	Behavioral: Genetic Testing and Counseling Behavioral: Screening Form	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Nov 23, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genetic Testing and Counseling Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.	Behavioral: Genetic Testing and Counseling Participants will complete testing
Experimental: 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	Behavioral: Screening Form Participants will complete forms with demographics and history

Arm

Intervention/Treatment

Experimental: Genetic Testing and Counseling

Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.

Behavioral: Genetic Testing and Counseling

Participants will complete testing

Experimental: 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

Behavioral: Screening Form

Participants will complete forms with demographics and history

Outcome Measures

Primary Outcome Measures

genetic risk screening tool (GRST) questionnaire [through study completion; an average of 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Banu Arun, MD, MD Anderson Cancer Cneter

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

MD Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05694559

Other Study ID Numbers:

2022-0328
NCI-2023-00252

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jan 23, 2023