Breast Cancer Clinical Trial

Informing Latinas About HBOC Risk

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.

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Full Description

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, FORCE, 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 FORCE Fact Sheet Arm. All participants in the randomized controlled trial will be offered genetic counseling and testing.

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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 is for people with:

Breast Cancer

Estimated Enrollment:

332

Study ID:

NCT05130606

Recruitment Status:

Enrolling by invitation

Sponsor:

Georgetown University

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There are 2 Locations for this study

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Georgetown Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20007, United States
Virginia Commonwealth University
Richmond Virginia, 23284, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

332

Study ID:

NCT05130606

Recruitment Status:

Enrolling by invitation

Sponsor:


Georgetown University

How clear is this clinincal trial information?

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