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Genetic Counseling and Testing in Latina Women At-Risk of Hereditary Breast and Ovarian Cancer

Trial Status: Active

This trial investigates the impact of an educational video compared to a fact sheet in enhancing the use of genetic counseling and testing for Latina women at-risk hereditary breast and ovarian cancer. Having a change or alteration (genetic mutation) in certain genes can increase the risk of developing breast and ovarian cancer. Latina women are less likely than non-Latina Whites to use genetic counseling and testing. Participating in genetic counseling and testing can inform important treatment and prevention decisions for individuals at risk of hereditary breast and ovarian cancer.

Inclusion Criteria

  • AIM 1 INCLUSION CRITERIA:
  • Self-identify as Latina
  • Fluent in Spanish
  • Meet National Comprehensive Cancer Network (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 other device
  • AIM 2 INCLUSION CRITERIA:
  • Works full-time or part-time at one our partner community clinics
  • Fluent in English or Spanish
  • Able to provide informed consent to participate

Exclusion Criteria

  • Adults unable to consent will be excluded from this study

District of Columbia

Washington
Capital Breast Care Center
Status: APPROVED
Contact: Nathaly Gonzalez
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Alejandra Hurtado de Mendoza
Phone: 202-687-8916
Nueva Vida, Inc.
Status: APPROVED
Contact: Claudia Campos
Phone: 202-229-9100

New Jersey

Hackensack
Hackensack University Medical Center
Status: APPROVED
Contact: Ciara Torres
Phone: 551-996-5779

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: IN_REVIEW
Contact: Vanessa B. Sheppard
Phone: 804-628-3083

PRIMARY OBJECTIVES:

I. Evaluate the impact of the video versus (vs.) FORCE fact sheet on genetic cancer risk assessment (GCRA) and testing uptake and psychosocial outcomes.

II. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the hereditary breast and ovarian cancer (HBOC) screening process at the community clinics.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch an educational video. Patients also complete a survey over 30 minutes at baseline, at 2 weeks, and at 3 months.

ARM II: Participants review the FORCE fact sheet. Patients also complete a survey over 30 minutes at baseline, at 2 weeks, and at 3 months.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
MedStar Georgetown University Hospital

Principal Investigator
Alejandra Hurtado de Mendoza

  • Primary ID STUDY00001436
  • Secondary IDs NCI-2020-06744
  • Clinicaltrials.gov ID NCT04544501