Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients

August 26, 2026 updated by: Alexandre Chan, University of California, Irvine

A Randomized Controlled, Type 1 Hybrid Effectiveness-implementation Trial Study to Compare 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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fan-Ying Chan, MS
  • Phone Number: 949-738-7135
  • Email: fanyinc@uci.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92617
        • Chao Family Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Being physically and/or mentally incapable of providing written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Patient-Reported Outcomes (PRO)-driven supportive care navigation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency department visits, hospitalizations, and urgent care visits
Time Frame: baseline and 3 months post-baseline
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.
baseline and 3 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity
Time Frame: baseline and 3 months post-baseline
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.
baseline and 3 months post-baseline
Health-related quality of life
Time Frame: baseline and 3 months post-baseline
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.
baseline and 3 months post-baseline
Health literacy
Time Frame: baseline and 3 months post-baseline
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.
baseline and 3 months post-baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-Reactive Protein (CRP) Level
Time Frame: baseline and 3 months post-baseline
Dried blood spot (DBS) sampling will be used to collect and analyze CRP level (mg/L)
baseline and 3 months post-baseline
Interleukin-1 Receptor Antagonist (IL-1RA) Level
Time Frame: Baseline and 3 months post-baseline
Dried blood spot (DBS) sampling will be used to collect and analyze IL-1RA level (pg/mL)
Baseline and 3 months post-baseline
Interleukin-6 (IL-6) Level
Time Frame: Baseline and 3 months post-baseline
Dried blood spot (DBS) sampling will be used to collect and analyze IL-6 level (pg/mL)
Baseline and 3 months post-baseline
Tumor Necrosis Factor-alpha (TNF-α) Level
Time Frame: Baseline and 3 months post-baseline
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-α level (pg/mL)
Baseline and 3 months post-baseline
TNF Receptor Type II (TNF-RII) Level
Time Frame: Baseline and 3 months post-baseline
Dried blood spot (DBS) sampling will be used to collect and analyze TNF-RII level (pg/mL)
Baseline and 3 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Alexandre Chan, PharmD, PhD, MPH, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 22, 2026

First Submitted That Met QC Criteria

August 22, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe