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NCT Number: NCT07787806

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chao Family Comprehensive Cancer Center

Irvine, California, 92617, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Reported Outcomes (PRO)-driven supportive care navigation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fan-Ying Chan, MS

CONTACT

[email protected]

949-738-7135

Matthew Heshmatipour, MPH

CONTACT

[email protected]

9494624610

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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