Abstract
10009 Background: Children with cancer living in poverty are more likely to relapse and die, even when treated uniformly on clinical trials. No evidence-based interventions targeting poverty as a risk factor for disparate outcomes exist in pediatric oncology. We previously developed and refined the Pediatric Cancer Resource Equity (PediCARE) intervention—a centrally-delivered, household material hardship (HMH)-targeted intervention that provides transportation and groceries to low-income pediatric oncology families. We report feasibility of administering PediCARE as a randomized intervention across 2-centers. Methods: We conducted a pilot randomized controlled trial (RCT) of PediCARE versus usual care at Dana-Farber Cancer Institute (DFCI) and University of Alabama Birmingham (UAB) between May 2019 and August 2021 (NCT03638453). Eligible participants included children age < 18 years with de novo cancer diagnosed in the prior 2-months, who were planned to receive at least 4-cycles of chemotherapy and lived in a household that screened positive for HMH (food, housing, utility or transportation insecurity). Participants were randomized 1:1 by site to receive PediCARE or usual care for 6-months. Parent/guardians completed a household survey at baseline and at completion of the 6-month intervention. The primary outcome was feasibility defined a priori as a recruitment and consent to randomization rate of > = 75% and < 20% attrition per arm—endpoints intended to justify the feasibility of a subsequent efficacy RCT. Secondary outcomes included proportion of recipients who successfully received the intervention and intervention acceptability. Results: A total of N = 40/40 eligible families (n = 12 UAB; n = 28 DFCI) were approached and offered an opportunity to participate (100% consent rate). Among participants, there was 0% attrition in either arm following randomization and the 6-month intervention period; 100% of parent/guardians completed both baseline and 6-month surveys. Among those randomized to PediCARE, 100% (n = 20) successfully received grocery and transportation resources; 100% reported that it was "easier to buy food for my family," 85% reported it was easier to get to and from the hospital, and 95% reported they would be “very likely to recommend the intervention to other families”. Conclusions: Stark disparities exist in pediatric oncology. Advancement in health equity science must include establishment of a robust, evidence-based portfolio of scalable health equity interventions for evaluation in the Children’s Oncology Group (COG) drug trial setting. Findings from this pilot RCT support feasibility and utility of a poverty-targeted intervention from the clinical oncology setting—as evidenced by 100% of parent/guardians consenting to randomization with 0% attrition across 2-centers. Immediate next steps include randomized efficacy evaluation in a COG trial-embedded study. Clinical trial information: NCT03638453 .
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