438 - Role of social determinants of health on parental consent and voluntariness in pediatric cancer clinical trials

Publication Number: 438.6286

Jean Wu, University of California, San Diego School of Medicine, La Jolla, CA, United States; Kate Marinchev, Rady Children's Hospital San Diego, 5265 Hewlett Dr, CA, United States; Paola Guerrero, Rady Children's Hospital San Diego, Albany, NY, United States; Yvonne Yu, University of California, San Diego School of Medicine, San Diego, CA, United States; Bianca Pamela. Perdomo, University of California, San Diego School of Medicine, La Jolla, CA, United States; Paula Aristizabal, University of California San Diego Department of Pediatrics, San Diego, CA, United States

Background: Voluntariness in informed consent for clinical trials is an ethical imperative and refers to the willingness to participate in research without feeling pressured. Although parental consent is required for participation of children in clinical trials, research assessing the role of social determinants of health (SDOH), particularly health literacy and use of Spanish language, on parental voluntariness in pediatric cancer clinical trials is limited. Health literacy is the ability to understand and act on medical information to effectively navigate healthcare, and limited health literacy is associated with poorer health outcomes. Thus, investigating and addressing SDOH during informed consent can contribute to improving persistent disparities in clinical trial accrual for marginalized populations.

Objective: To examine associations between SDOH and voluntariness during informed consent for clinical trials among parents of children with cancer.

Design/Methods: This cross-sectional study prospectively enrolled parents/legal guardians of children newly-diagnosed with cancer at an academic children’s hospital from 2014 to 2023. Associations between socio-demographics, SDOH and voluntariness, including subdomains of self-control and absence of control, were assessed using multivariable regression.

Results: Of 354 participants, 189 self-identified as Hispanic (53.4%), 230 were female (65.0%), 110 used Spanish for medical communication (31.1%), and 131 had limited health literacy (37.0%). In univariate analysis, lower voluntariness was significantly associated with unemployment (r=-1.490, p=0.042), Spanish language use (r=-3.331, p< 0.001), and limited health literacy (r=2.477, p=0.002); higher voluntariness was associated with private insurance (r=1.982, p=0.010) and college education (r=1.894, p=0.019). In multivariable analysis, lower voluntariness remained significantly associated with the use of Spanish language (r=-3.067, p=0.002) and limited health literacy (r=-2.132, p= 0.006). Further, in multivariate analysis, Spanish language was associated with lower perception of self-control (r=-0.664, p=0.053); and Spanish language use (r =-1.848, p< 0.001) and limited health literacy (r=-0.762, p=0.030) were associated with an absence of control.

Conclusion(s): Lower parental voluntariness was significantly associated with Spanish language use for medical communication and limited health literacy. Our findings emphasize the urgent need for health literacy and language-concordant recruitment interventions to ensure voluntary and equitable research participation.