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CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing

NCT05130606 · Georgetown University
In plain English

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Official title
Testing a Narrative Intervention to Enhance Genetic Counseling and Testing
About this study
The investigators previously developed and piloted a culturally targeted narrative video in Spanish to provide HBOC and GCT education to at-risk Latinas. The investigators expanded traditional approaches to address psychosocial barriers through risk messages designed to elicit emotional responses; emotions are often stronger predictors of behavior than cognition. Our video is responsive to Latinas' preferences, targets motivators, and addresses psychosocial barriers identified in our formative research. In this study, the investigators aim to evaluate the efficacy of our video vs. a fact sheet from an established group on enhancing GCT uptake and psychosocial outcomes on a two-arm randomized controlled trial. The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using an adapted Risk Screening Tool (RST) and video in community clinics. The investigators will partner with community clinics and implement a Risk Screening Tool (RST) at their practice to identify women at risk of HBOC. Community clinic staff (N\~32) will be asked to participate in a pre-implementation and a post-implementation focus group to assess implementation outcomes of integrating HBOC screening practices in their clinic. Through the community clinics, the investigators aim to recruit N\~300 Latina women at risk for HBOC based on their personal or family history of cancer. Latina women at risk for HBOC will be randomized to a Video arm or Fact Sheet Arm. All participants in the randomized controlled trial will be offered genetic counseling and testing.
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: \-
Study design
Enrollment target: 332 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-06-01
Estimated completion: 2025-12-31
Last updated: 2025-08-28
Interventions
Behavioral: Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."Behavioral: FORCE Fact Sheet
Primary outcomes
  • Uptake of Genetic Counseling (Change from the baseline survey to four months after baseline)
  • Uptake of Genetic Testing (Change from the baseline survey to four months after baseline)
Sponsor
Georgetown University · other
With: National Cancer Institute (NCI), Virginia Commonwealth University
Contacts & investigators
ContactAlejandra Hurtado de Mendoza, Ph.D · contact · ahd28@georgetown.edu · 2026878916
InvestigatorAlejandra Hurtado de Mendoza, Ph.D · principal_investigator, Georgetown Lombardi Comprehensive Cancer Center
All locations (2)
Georgetown Lombardi Comprehensive Cancer CenterRecruiting
Washington D.C., District of Columbia, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
CONTIGO - A Narrative Intervention to Enhance Genetic Counseling and Testing · TrialPath