An interventional study of Patient-Reported Outcomes (PRO)-driven supportive care navigation in Cancer, sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Supportive care
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Patient-Reported Outcomes (PRO)-driven supportive care navigation
Patients 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.
Time frame: baseline and 3 months post-baseline
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.
Time frame: baseline and 3 months post-baseline
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.
Time frame: baseline and 3 months post-baseline
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.
Time frame: baseline and 3 months post-baseline
C-Reactive Protein (CRP) Level
Dried blood spot (DBS) sampling will be used to collect and analyze CRP level (mg/L)
Time frame: baseline and 3 months post-baseline
Interleukin-1 Receptor Antagonist (IL-1RA) Level
Dried blood spot (DBS) sampling will be used to collect and analyze IL-1RA level (pg/mL)
Time frame: Baseline and 3 months post-baseline
Interleukin-6 (IL-6) Level
Dried blood spot (DBS) sampling will be used to collect and analyze IL-6 level (pg/mL)
Time frame: Baseline and 3 months post-baseline
Tumor Necrosis Factor-alpha (TNF-α) Level
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-α level (pg/mL)
Time frame: Baseline and 3 months post-baseline
TNF Receptor Type II (TNF-RII) Level
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-RII level (pg/mL)
Time frame: Baseline and 3 months post-baseline
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Irvine →