CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT05130606
Status
Recruiting
Apply to this trial

Conditions

  • Hereditary Breast and Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." — BEHAVIORAL
    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.
  • FORCE Fact Sheet — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Video Arm
    Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." Participants in the video arm will be asked to watch an 18-minute video that the research team developed and tested previously about HBOC and genetic services. The video is recorded with Spanish audio and is available with English subtitles.
  • Active Comparator: Fact Sheet Arm
    Participants in the Fact Sheet arm will receive a Fact sheet about HBOC and genetic services and will be asked to read it in their own time. The Fact Sheet is available in English and Spanish.

Primary Outcome Measure

Uptake of Genetic Counseling [ Time Frame: Change from the baseline survey to four months after baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Alejandra Hurtado de Mendoza, Ph.D.
[email protected]
202-687-8916
Virginia Commonwealth UniversityRichmondVirginia23284
Yvonne Cummings
[email protected]
804-828-0643
Vanessa Sheppard, Ph.D
[email protected]
Vanessa Sheppard, Ph.D (PRINCIPAL_INVESTIGATOR)

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