Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID05130606

Testing a Narrative Intervention to Enhance Genetic Counseling and Testing in Latina Women at Risk for Hereditary Breast and Ovarian Cancer

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

332

Participants Needed

2

Research Sites

N/A

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

Researchers are evaluating a culturally targeted video compared to a Spanish-language fact sheet to improve genetic counseling and testing among Latina women at risk for hereditary breast and ovarian cancer (HBOC). This mixed-methods study combines a two-arm randomized controlled trial and a process evaluation to understand the effectiveness and implementation of these tools in community clinics. The study aims to address psychosocial barriers and motivators related to genetic services uptake in this population. Participants will be randomly assigned to either watch an 18-minute narrative video, available in Spanish with English subtitles, or receive a fact sheet about HBOC and genetic services in Spanish or English. The video is designed to evoke emotional responses and is delivered via a secure link or DVD. The fact sheet is provided as a PDF or printed copy. Community clinics will use an adapted Risk Screening Tool (RST) to identify eligible women, and clinic staff will participate in focus groups to assess implementation outcomes. Women who join the study will be assessed at baseline and followed for four months. Researchers will track uptake of genetic counseling and testing, changes in knowledge, self-efficacy, attitudes, norms, and emotions related to genetic risk assessment. Participants will complete surveys at baseline, two weeks, and four months post-baseline. The study also evaluates how well the intervention fits into community clinics and its acceptability and feasibility. Total participation includes initial screening, intervention delivery, and follow-up assessments.

CONDITIONS

Brief 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
  • Able to provide informed consent
  • Fluent in Spanish
  • Meet criteria for genetic cancer risk assessment for hereditary breast and ovarian cancer based on personal or family history
  • No previous genetic counseling or testing for hereditary breast and ovarian cancer risk
  • No other family members participating in this study
  • Not participated in previous studies involving interventions about hereditary breast and ovarian cancer or genetic counseling and testing
  • For community clinic staff: be 18 years or older, fluent in English or Spanish, and work as employee, intern, or volunteer at partner clinic
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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to determine eligibility

Treatment

Duration - Up to 4 months

Participants are randomized to receive either a culturally targeted narrative video or a fact sheet about hereditary breast and ovarian cancer and genetic services. They will watch the video or read the fact sheet on their own time.

1 baseline visit plus follow-up surveys at 2 weeks and 4 months after baseline

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

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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