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CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

NCT05130606 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

  • Hereditary Breast and Ovarian Cancer

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Virginia Commonwealth University

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Alejandra Hurtado de Mendoza, Ph.D · Georgetown Lombardi Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130606 on ClinicalTrials.gov