A Randomized Controlled Trial to Compare the Effectiveness of a Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07787806
Status
Not Yet Recruiting

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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual care
  • Experimental: Patient-Reported Outcomes (PRO)-driven supportive care navigation

Primary Outcome Measure

ED visits, hospitalizations, and urgent care visits [ Time Frame: baseline and 3 months post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CenterIrvineCalifornia92617-

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