This is a randomized controlled, type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a patient-reported outcomes (PRO)-driven culturally grounded supportive care navigation in reducing healthcare disparities among Hispanic/Latinx patients receiving anticancer therapies. The objectives of this study are: (1) to compare the effectiveness of an ePRO-driven culturally grounded supportive care navigation versus usual care (control) in Hispanic/Latinx patients undergoing anticancer treatment; and (2) to elicit perspectives from Hispanic/Latinx patients, healthcare providers, and community partners on how an ePRO-driven culturally grounded supportive care navigation can address health disparities.
At least 18 years old
Hispanic/LatinX origin
Newly diagnosed cancer patients
Receiving anticancer treatment (may include combinations of intravenous or oral chemotherapy, targeted therapies, and/or immunotherapies)
Being physically and/or mentally incapable of providing written consent
Parallel
Patient-Reported Outcomes (PRO)-driven supportive care navigation
Other interventionPatients within the intervention arm will receive ePRO-driven supportive care navigation consisting of: (1) routine distress screening and care needs assessment; (2) machine learning-based acute care utilization risk prediction; (3) culturally grounded supportive care navigation; and (4) community follow-up.
Emergency department visits, hospitalizations, and urgent care visits
Detailed information regarding emergency department visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using electronic medical records, and the UCI Health Data Warehouse.
Health-related quality of life
Quality of life will be measured Patient-Reported Outcomes Measurement Information System Global Health (PROMIS Global Health), a 10-item Likert scale (questions 1-8 and 10 on a 5-point scale and question 9 on an 11-point scale) instrument yielding two scores, physical health and mental health, where higher scores indicate better health.
Symptom severity
Symptom severity will be assessed by the Edmonton Symptom Assessment System (ESAS), an 11-point Likert scale (0-10) that measures symptom intensity. A change of at least one point is considered clinically meaningful, with higher scores indicating greater symptom burden.
Health literacy
Health literacy will be assessed using the Brief Health Literacy Screening (BHLS) tool, with each item rated on a 5-point scale from 1 to 5, yielding a total score ranging from 3 to 15. Higher scores indicate better health literacy.
C-Reactive Protein (CRP) Level
Dried blood spot (DBS) sampling will be used to collect and analyze CRP level (mg/L)
Interleukin-1 Receptor Antagonist (IL-1RA) Level
Dried blood spot (DBS) sampling will be used to collect and analyze IL-1RA level (pg/mL)
Interleukin-6 (IL-6) Level
Dried blood spot (DBS) sampling will be used to collect and analyze IL-6 level (pg/mL)
Tumor Necrosis Factor-alpha (TNF-α) Level
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-α level (pg/mL)
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