The "Latines Lideres En Salud (LaLiSa)" study: Rationale and design

Contemp Clin Trials. 2024 Nov:146:107689. doi: 10.1016/j.cct.2024.107689. Epub 2024 Sep 13.

Abstract

Background: Latines suffer from breast cancer (BC), due to elevated biological and social determinants of health (SDOH) risks. This study compares the effects of different strategies on uptake of cancer genetic services, specifically hereditary cancer risk assessment, genetic counseling, and genetic testing, and risk-based BC care.

Design/methods: In Chicago, Illinois, Aim 1 participants are recruited from a federally qualified health center (FQHC) and community venues. For Aim 1, eligible participants: (1) are female; (2) are Latine; (3) are 30+ years old; (4) have personal or family history of BC or cancers with shared hereditary mutations; (5) have at least one SDOH risk; and (6) have not received any cancer genetic services. Participants are randomly assigned to different study arms. Both arms include phone-based sessions, FQHC-based navigation for SDOH, and low- or no-cost cancer genetic services. The educate sessions focus on risk assessment and prevention. The empower sessions focus on risk assessment and equip participants with the skills to share information about FQHC-based cancer genetic services. For Aim 2, eligible participants are: (1) female; (2) network members of Aim 1 participants; and (3) eligible for BC screening based on guidelines recommended by the American Cancer Society (ACS). Primary outcomes include uptake of any cancer genetic services. Analyses will also explore intervention differences by neighborhood context.

Discussion: This is one of the first trials focused on Latines' participation in cancer genetic services and risk-based BC care within the context of SDOH - which has major implications for equity in precision cancer prevention.

Keywords: Breast cancer; Genetic risk; Health disparities; Latines.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Breast Neoplasms* / genetics
  • Chicago
  • Female
  • Genetic Counseling* / methods
  • Genetic Counseling* / organization & administration
  • Genetic Predisposition to Disease
  • Genetic Testing* / methods
  • Hispanic or Latino
  • Humans
  • Middle Aged
  • Patient Navigation / organization & administration
  • Randomized Controlled Trials as Topic
  • Research Design
  • Risk Assessment / methods
  • Social Determinants of Health