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RECRUITING
NCT05130606
NA

CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Sponsor: Georgetown University

View on ClinicalTrials.gov

Summary

This is a mixed-methods Hybrid Type 1 research design (efficacy study) in which we aim to conduct a two-arm randomized controlled trial and an Implementation Focused Process Evaluation of a culturally-targeted video and referral screening tool. In this study, the investigators aim to evaluate the efficacy of a culturally targeted video previously developed by the research team vs. a Spanish-language fact sheet from an established group on enhancing genetic counseling and testing uptake and psychosocial outcomes in Latina women at risk for hereditary breast and ovarian cancer. The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using the Risk Screening Tool (RST) and video in community clinics.

Official title: Testing a Narrative Intervention to Enhance Genetic Counseling and Testing

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2021-06-01

Completion Date

2025-12-31

Last Updated

2025-08-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."

Participants randomized to the video arm will receive a link with a password by email or text message to watch the video, depending on participants' preference. Participants without internet access will receive a DVD. Participants will be instructed to watch the video alone with no interruptions. We will ask them not to share the link with others.

BEHAVIORAL

FORCE Fact Sheet

Participants will receive a PDF of the fact sheet by email, text message, or a printed fact sheet by mail depending on participants' preferences. The fact sheet includes information about genes, breast cancer, risk factors for HBOC, genetic counseling and testing, and resources.

Locations (2)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Virginia Commonwealth University

Richmond, Virginia, United States