Multisite Implementation of COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn) to improve participation of Hispanic children in cancer clinical trials

PROJECT SUMMARY Childhood cancer is the leading cause of death by disease past infancy in the U.S. While survival rates are improving, stark racial/ethnic disparities remain. Hispanic children have a significantly higher incidence of several cancers, and inferior overall survival than their non-Hispanic White (NHW) counterparts. Although

clinical trial enrollment is linked to higher survival and NIH mandates appropriate inclusion of minorities in clinical trials, Hispanic children with cancer are significantly underrepresented in cancer clinical trials compared to NHWs. Given that Hispanics will comprise 33% of the U.S. childhood population by 2030, there is an urgent

need to identify effective interventions to overcome low trial accrual to equitably benefit Hispanics. Novel data from our group suggest that inadequate research literacy (capacity to understand and act on information to make decisions about research) is a barrier to participation in clinical trials. There are major gaps in knowledge

about interventions to improve research literacy and clinical trial participation for Hispanic children. This R01 is informed by the PI’s peer navigation intervention developed during her K08 award, “COMPRENDO” (ChildhOod Malignancy Peer REsearch NavigatiOn). COMPRENDO (adapted from the evidence-based patient

navigation model) involves trained peers (parents) who deliver culture, language, and health literacy- concordant education to parents/guardians of children with cancer during informed consent for therapeutic clinical trials. In our pilot feasibility study, COMPRENDO was feasible, highly acceptable by stakeholders and

increased parental informed consent comprehension and voluntariness (willingness to participate in research without feeling pressured). The logical next step is to test COMPRENDO effectiveness on a larger scale. We will study COMPRENDO in a multisite effectiveness-implementation randomized clinical trial (RCT) in 4 sites

with diverse populations of Hispanics. Our long-term goal is to implement generalizable, targeted, effective, and reproducible peer navigation interventions to enhance minority accrual to clinical trials. The overarching objective of this R01 is to increase clinical trial accrual in Hispanic children with cancer by improving research

literacy in their parents in a Hybrid Type 1 design to both test COMPRENDO effectiveness and explore multisite implementation determinants. Hispanic parents will be randomized to COMPRENDO or usual care [informed consent with the oncologist only]. We will measure child-centered (accrual) and parent-centered

(comprehension, voluntariness, decisional regret, decision-making self-efficacy, and satisfaction) outcomes. Impact: This research is significant as it addresses an understudied area by yielding actionable knowledge on how peer navigation can improve research literacy. Developed with stakeholder input, COMPRENDO is

innovative for its targeted peer navigation and its implementation evaluation in a multisite RCT to inform scale up. COMPRENDO has the potential to increase clinical trial accrual in Hispanics across the age continuum, enabling the equitable translation of discoveries and therapies, which is a top priority for NCI.