Recruiting

Video vs. Fact Sheet

Sponsor:

Georgetown University

Code:

NCT05130606

Conditions

Hereditary Breast and Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

FORCE Fact Sheet

Study Details

Brief 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

Study ID

NCT05130606

Start date

Jun 1, 2021

Status verified date

Aug, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Aim 1 and 2.

  • 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 to be considered for genetic cancer risk assessment for HBOC, whether by a personal history of cancer or family history of cancer
  • No previous participation in genetic counseling or testing for hereditary breast and ovarian cancer risk
  • No other family members are participating in this study
  • Have not participated in any previous studies involving interventions about HBOC or GCT

Aim 3.

  • Be 18 years old or older
  • Be fluent in English or Spanish
  • Have a role in the partner community clinic as either a) full-time or part-time employee b) intern c) volunteer

Exclusion Criteria:

\-

Study Design

Enrollment

332 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alejandra Hurtado de Mendoza, Ph.D

2026878916ahd28@georgetown.edu

Locations

Georgetown Lombardi Comprehensive Cancer Center

Recruiting

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

Contacts

Alejandra Hurtado de Mendoza, Ph.D.

202-687-8916ahd28@georgetown.edu

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Yvonne Cummings

804-828-0643Yvonne.Cummings@vcuhealth.org

Vanessa Sheppard, Ph.D

Vanessa.Sheppard@vcuhealth.org

Principal Investigator:

Vanessa Sheppard, Ph.D

More Information

Sponsor

Georgetown University

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Keywords

  • Breast cancer
  • Ovarian cancer
  • Hereditary cancer
  • Latinas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2025-08-28.