Prospective Observational Cohort Study to Collect Granular Social Determinants of Health Data for Transplant and Cellular Therapy Candidates and Recipients
Authors: Fingrut Warren B , Codrington KaNoisha , Hunter Ligny , Garcia Ricky , Martinez Charles , Rondon Gabriela , Milton Denái R. , Flowers Christopher R. , Shpall Elizabeth J. 
Published: December 2024

Background and Significance: Although patient social/ financial barriers impact transplant and cellular therapy (TCT) outcomes (e.g. Fingrut et al., Blood Adv. 2023), prospectively collected, comprehensive, granular data concerning the social determinants of health (SDOH) are not routinely collected across the TCT field.

Study design and Methods: We launched a single center, prospective, observational cohort study to determine TCT patients' social/ financial barriers to care (clinicaltrials.gov NCT06431347). The primary objective for the study is to determine the relationship between patient SDOH and TCT outcomes at MDACC. We hypothesize that: 1) SDOH barriers compromise the provision of TCT, and disproportionately impact patients from underserved racial/ ethnic populations; and 2) prospective data collection on patient social and financial barriers to provision of TCT is feasible.

A dedicated staff member records detailed SDOH data across multiple domains for patients ≥18 years with TCT financial approval, after providing a detailed rationale as to why these data are needed. Given the lack of standardized SDOH data collection tools in oncology, to facilitate this data collection, we adapted elements from existing, validated questionnaires (eg CMS Social Needs Screening Tool, Your Current Life Situation Screening Questionnaire). The questionnaire confirms patient demographic variables (ie race/ ethnicity and ancestry, sexual orientation, gender identity, disability, primary insurance, neighborhood poverty), and records social barriers (ie related to primary language/ confidence speaking English at home/ with the healthcare team, education level, employment history, immigration status, health literacy, legal/ incarceration history, caregiver status/literacy), financial barriers [ie income bracket, insecurity with cost-of-living (food, housing, utilities, transportation, childcare) / medical (insurance/ medication) expenses, housing issues (e.g. mold, pests), COST-FACIT score], and any financial supports accessed. Follow-up questionnaires will be administered at 6 month intervals through 2 years post-TCT and will ask patients about financial barriers and support accessed in the past 6 months.

The association between race/ethnicity and financial barriers (COST-FACIT Score &gt;24) with provision of TCT will be assessed using univariable and multivariable logistic regression models, including key covariates such as patient's age and gender as well as comorbidities (HCT-CI), graft source, and conditioning regimen. Results from all other social/ financial questions will be reported descriptively, and SDOH assessments over time will be evaluated using generalized linear mixed modeling.

The study is currently recruiting patients.

Conclusions: We report, to our knowledge, the first ever process to prospectively collect comprehensive, granular SDOH data for patients across a department at a large cancer center. This study will address gaps in available patient-level SDOH data to permit TCT disparity and patient representation analyses, inform pilot interventions to address inequities, and support standardized SDOH data collection processes in the TCT field and across oncology. Multicenter adoption with CIBMTR data sharing will permit large-scale outcome analyses to further interrogate TCT disparities.