Discussion
Trial-embedded evaluation of patient-reported SDoH is feasible and
acceptable as evidenced by high participation and response rates, low
data missingness, and minimal attrition in the first pediatric oncology
trial-embedded SDoH study. Baseline SDoH surveys were completed during
ALL induction therapy—frequently a time of high clinical acuity and
family stress—with a response rate of nearly 96%, demonstrating both
the feasibility of early data collection and the salience families place
on sharing these data with researchers. We identified no significant
differences in baseline characteristics between the overall trial cohort
and SDoH cohort study participants, indicating acceptability of this
trial-embedded study approach to a representative population of
families. Finally, this study successfully collected SDoH survey data
from families regardless of language (including English, Spanish,
French, Russian, and Portuguese) utilizing an equity-based approach that
allowed survey administration with an appropriate interpreter.
Adverse SDoH are highly prevalent within the US population, with poverty
as a key example. Nearly one in six US children live in households that
meet the federal definition of income poverty,14 and
poverty is associated with higher rates of relapse, lower overall
survival, and inferior patient- and parent-reported
outcomes.2,8,15,16 Given that the financial toxicity
of cancer therapy—including economic burdens of travel to and lodging
near treating institutions, out-of-pocket medical expenses, and foregone
parental income due to treatment-related work disruptions—can cause or
exacerbate financial hardship for families,13,17,18longitudinal assessment of SDoH over the course of cancer therapy is
critical, and feasible as demonstrated by low attrition rates in our
study.
These feasibility data directly challenge the narratives that patients
are hesitant to share sensitive sociodemographic/socioeconomic
information in a clinical-trial context, and that patient-reported SDoH
data collection is overly burdensome to sites or participants. Pediatric
oncology has embraced the systematic collection of identified biological
risk factors for outcome even absent effective drug interventions, in
order to inform future interventional research. Vital next steps include
integration of SDoH data collection in cooperative group trials
alongside collection of biological risk factors, and development and
evaluation of trial-embedded health-equity
interventions.19 This effort will require
institutional and payor-level commitment to funding scalable
social-needs care delivery models.
Limitations of this study include demonstration of feasibility within a
small (8-center) consortium with sites limited to the US East Coast and
Canada. Evaluation of similar trial-embedded SDoH collection is ongoing
in Children’s Oncology Group trials across >180 sites. As
detailed sociodemographic data are not routinely collected in trial
case-report forms, we are unable to determine whether SDoH study
non-participants differ from participants on the basis of family income,
insurance status, or other SDoH. Finally, this study design utilized an
opt-in approach at time of trial consent given lack of feasibility data
regarding collection of SDoH in a trial setting. While we observed no
differences between participants and non-participants in our study, this
methodological approach reinforces the preconception that these data are
not important to families and may lead to bias in data collection.
Future studies must integrate SDoH data collection as a required
component of clinical trials based on evidence of salience to child
outcomes and feasibility of collection.
Achieving health equity in disease outcomes is paramount and cannot be
accomplished in the absence of SDoH data to guide design and evaluation
of interventions. SDoH data collection must become standard practice
within oncology clinical trials, alongside trial-embedded health equity
interventions to ameliorate outcome disparities.