Methods
The Dana-Farber Cancer Institute (DFCI) Acute Lymphoblastic Leukemia (ALL) Consortium phase III randomized clinical trial 16-001 (clinicaltrials.gov ID: NCT03020030) enrolled children with de novo ALL aged 1-<22 years at 8 US and Canadian centers from 2016-2021. DFCI 16-001 included an embedded study to prospectively evaluate parent-reported SDoH and outcome disparities, powered to investigate household material hardship (HMH: food, utility, or housing insecurity) as the primary SDoH exposure. At trial consent, parents/guardians of children <18 years of age were eligible to opt-in to the SDoH study. Parents completed a 50-item survey (English, Spanish, French-Canadian, or any language with interpreter) in-person or by telephone or remote video platform with research personnel within 32 days of enrollment (T0), and longitudinally at 6, 12 and 24 months of therapy (T1-T3). Surveys were preferentially read aloud to participants to overcome health literacy barriers, though self-completion of paper surveys was allowed. Parent-reported SDoH data included parent language, health literacy, and education; household income; and HMH; as well as parent-reported child race and ethnicity.13 SDoH were collected as confidential research data, and neither evaluated in real-time nor shared with treating oncology teams. DFCI 16-001 was approved by the DFCI Institutional Review Board (IRB) and site IRBs.
Among the SDoH study-eligible cohort, we compared baseline demographic and disease-related data between participants (defined as those who completed T0 survey) and non-participants (those who declined opt-in consent, or provided consent but did not complete T0) using Wilcoxon rank-sum test for continuous variables and Fisher exact test for categorical variables. Statistical analysis was performed using SAS version 9.4.