Testing a Narrative Intervention to Enhance Genetic Counseling and Testing

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Washington, D.c.
Georgetown Lombardi Comprehensive Cancer Center
RECRUITING
Washington D.c.
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Alejandra Hurtado de Mendoza, Ph.D
ahd28@georgetown.edu
2026878916
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 332
Treatments
Experimental: Video Arm
Culturally Targeted Narrative Video: Is My Cancer Hereditary? Rosa Visits a Genetic Counselor. Participants in the video arm will be asked to watch an 18-minute video that the research team developed and tested previously about HBOC and genetic services. The video is recorded with Spanish audio and is available with English subtitles.
Active_comparator: Fact Sheet Arm
Participants in the Fact Sheet arm will receive a Fact sheet about HBOC and genetic services and will be asked to read it in their own time. The Fact Sheet is available in English and Spanish.
Related Therapeutic Areas
Sponsors
Collaborators: Virginia Commonwealth University, National Cancer Institute (NCI)
Leads: Georgetown University

This content was sourced from clinicaltrials.gov