NCT05130606 CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing
| NCT ID | NCT05130606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Hereditary Breast and Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 332 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 332 participants in total. It began in 2021-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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: \-
Contact & Investigator
Alejandra Hurtado de Mendoza, Ph.D
PRINCIPAL INVESTIGATOR
Georgetown Lombardi Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05130606 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hereditary Breast and Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05130606 currently recruiting?
Yes, NCT05130606 is actively recruiting participants. Contact the research team at ahd28@georgetown.edu for enrollment information.
Where is the NCT05130606 trial being conducted?
This trial is being conducted at Washington D.C., United States, Richmond, United States.
Who is sponsoring the NCT05130606 clinical trial?
NCT05130606 is sponsored by Georgetown University. The principal investigator is Alejandra Hurtado de Mendoza, Ph.D at Georgetown Lombardi Comprehensive Cancer Center. The trial plans to enroll 332 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.