Culturally targeted Spanish video to boost genetic counseling and testing for Latinas at risk for hereditary breast and ovarian cancer.
Testing a Narrative Intervention to Enhance Genetic Counseling and Testing
Try a short Spanish narrative video versus a Spanish fact sheet to see if it helps Latina women at risk for hereditary breast and ovarian cancer get genetic counseling and testing and feel more supported.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Georgetown University Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT05130606 on ClinicalTrials.gov |
What this trial studies
This is a two-arm randomized study enrolling about 300 Latina women identified as at risk for hereditary breast and ovarian cancer using an adapted Risk Screening Tool in partner community clinics. Eligible participants who are Spanish-fluent and meet NCCN criteria will be randomized to watch a culturally targeted narrative video or receive a Spanish-language fact sheet, with primary outcomes including uptake of genetic counseling and testing and psychosocial measures. The design is a Hybrid Type 1 effectiveness/implementation model, collecting implementation data from clinic staff via pre- and post-implementation focus groups to assess feasibility and sustainability. The investigators previously developed and piloted the video and will use mixed methods to link efficacy results with real-world implementation factors.
Who should consider this trial
Good fit: Latina-identifying women aged 18 or older who are fluent in Spanish, meet NCCN criteria for HBOC genetic risk assessment, have not previously had HBOC genetic counseling or testing, and can provide informed consent.
Not a fit: Women who already had genetic counseling or testing for hereditary breast and ovarian cancer, those who are not fluent in Spanish, or those who do not meet NCCN risk criteria are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could increase genetic counseling and testing uptake among at-risk Latinas and lessen psychosocial barriers to pursuing testing.
How similar studies have performed: The study team previously piloted this exact culturally targeted video with promising acceptability, and other culturally tailored education efforts have shown mixed but encouraging effects on counseling and testing uptake.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Alejandra Hurtado de Mendoza, Ph.D — Georgetown Lombardi Comprehensive Cancer Center
- Study coordinator: Alejandra Hurtado de Mendoza, Ph.D
- Email: ahd28@georgetown.edu
- Phone: 2026878916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.