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.