Enhance the Use of Genetic Counseling and Testing in Latinas
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome
- Interventions
- Behavioral: Culturally-Targeted VideoOther: FORCE Fact Sheet
- Registration Number
- NCT04544501
- Lead Sponsor
- Georgetown University
- Brief Summary
The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).
- Detailed Description
The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).
All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations \[Georgetown University (DC); Virginia Commonwealth University (VA)\].
Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.
Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.
Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- Older than 18 years-old
- Self-identify as Latina
- Fluent in Spanish
- Meet NCCN criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer
- Have not received genetic counseling or genetic testing
- Able to provide informed consent
- No other members of the same family have participated
- Must have access to the internet via smartphone, computer, or another device.
- Not fluent in Spanish
- Previously received genetic counseling or genetic testing for HBOC
- Previously participated in another interventional study about HBOC and GCRA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Culturally-Targeted Video Culturally-Targeted Video - FORCE Fact Sheet FORCE Fact Sheet -
- Primary Outcome Measures
Name Time Method Genetic counseling uptake Baseline survey to three months after baseline Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records.
- Secondary Outcome Measures
Name Time Method Genetic testing uptake Baseline survey to three months after baseline Proportion of participants that receive genetic testing. The outcome will be assessed by self-report (e.g., Have you received genetic testing in the past three months?) and confirmed with the genetic counseling company records.
Trial Locations
- Locations (4)
Capital Breast Care Center
🇺🇸Washington, District of Columbia, United States
Nueva Vida
🇺🇸Alexandria, Virginia, United States
Arlington Free Clinic
🇺🇸Arlington, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States