NCT05130606Completed
CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing
Testing a Narrative Intervention to Enhance Genetic Counseling and Testing
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 289 (actual)
- First submitted
- 7 Sept 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Georgetown University
- Diseases
- Ovarian cancer
- NCT number
- NCT05130606
What you commit to
- Study type: Interventional
- Participants enrolled: 289
- From 1 Jun 2021 to the primary completion date, 30 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
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Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Georgetown Lombardi Comprehensive Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.