Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05130606

CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Led by Georgetown University · Updated on 2025-08-28

332

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identify as a Latina woman
  • Be 18 years old or older
  • Be able to provide informed consent
  • Be fluent in Spanish
  • Meet NCCN criteria for genetic cancer risk assessment for HBOC by personal or family cancer history
  • Have no previous genetic counseling or testing for hereditary breast and ovarian cancer risk
  • Have no other family members participating in this study
  • Have not participated in previous studies involving interventions about HBOC or genetic counseling and testing
  • Be 18 years old or older (for community clinic staff)
  • Be fluent in English or Spanish (for community clinic staff)
  • Have a role in the partner community clinic as full-time or part-time employee, intern, or volunteer (for community clinic staff)
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 2 locations

1

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

2

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Actively Recruiting

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Research Team

A

Alejandra Hurtado de Mendoza, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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