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.