Improving access to pediatric oncology clinical trials: Identifying modifiable enrollment barriers.

Abstract

e13818 Background: Clinical trial participation is associated with improved childhood cancer outcomes. There are certain groups with less access to pediatric clinical trial participation. Relationships among modifiable factors driving these differences such as poverty, household material hardship (HMH), and health literacy (HL) are unknown. Identifying modifiable barriers to research enrollment and participation is essential to improving childhood cancer outcomes. The aim of this study was to compare caregiver-reported barriers to pediatric oncology clinical trial enrollment and participation between underrepresented and represented racial groups and between adequately resourced and underserved socioeconomic status (SES) groups. Methods: English and/or Spanish-speaking caregivers of children diagnosed with cancer in the last 5 years anonymously completed the Research Participation Survey (RPS) and the HLS19-Q12 health literacy assessment. On the RPS, caregivers rated 16 barriers to clinical trial participation on a 5-point Likert scale (1 = not at all true, 5 = very true). Analyses of covariance were used to compare RPS mean barrier scores between represented and underrepresented racial/ethnic groups and between adequately resourced and underserved SES groups while controlling for previous clinical trial participation. The underrepresented race/ethnicity group included caregivers who self-identified as non-White, and/or Hispanic. The underserved SES group included caregivers experiencing HMH, which was defined by endorsing > 1/3 of the following items – food insecurity, housing instability, and household income < 30th percentile on 2020 US census. Results: Participating caregivers (n = 59) spanned a broad geographic distribution. Over half (51%) of participants identified as racially/ethnically underrepresented and 64% were socioeconomically underserved. The majority (63%) of caregivers reported their child had not participated in a pediatric oncology clinical trial. Adequately resourced caregivers reported significantly lower barrier scores than underserved caregivers (F = 6.101, p = 0.004). There were no significant differences in barrier scores across underrepresented vs represented racial/ethnic groups (p = 0.102). Lower HL was correlated with higher barrier scores (R = -0.557, p < 0.001). Caregivers most frequently identified difficulty understanding risks of study participation (> 90%), difficulty paying for food, rent, and other bills (59%), concerns about missing too much work or school (51%), and childcare for other family members (41%) as barriers to clinical trial participation. Conclusions: In a sample of caregivers of children with cancer, HMH and low HL were significantly associated with increased barriers to pediatric oncology clinical trial enrollment. Caregivers most frequently identified modifiable barriers to participation that could be targets for intervention to increase access in childhood cancer outcomes.