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Clinical Trials/NCT07568457
NCT07568457Not yet recruitingNot Applicable

A Randomized Controlled Interventional Trial of a Social Determinants of Health and Patient Navigation Program to Improve Treatment Utilization Among Low-income Patients With Hepatocellular Carcinoma

University of Southern California3 sites in 1 country75 target enrollmentStarted: June 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
75
Locations
3

Study Overview

Brief Summary

The goal of this study is to test whether providing various social resources (transportation support through Lyft rides, housing support through Hyatt House LA, and meal support through Project Angel Food LA) will reduce treatment delays and increase treatment uptake for patients with liver cancer.

Detailed Description

Social determinants of health (SDOH) play a central role in drop-offs at each step of the cancer care cascade for patients living in poverty. Social barriers have been shown to result in delays in care, increased non-compliance, and poorer outcomes. Importantly, negative SDOH among patients with HCC may impact receipt of therapy, a critical contributor to improved survival. Studies have shown that even small delays in therapy (more than 3 months from diagnosis) can lead to worse survival. The treatment landscape for HCC is complex, ranging from surgical options to locoregional therapies to immunotherapy, and requires multidisciplinary input from hepatologists, oncologists, interventional radiologists, and surgeons and frequent touchpoints with the healthcare system to successfully complete treatment. Social barriers can make navigating these complexities especially challenging for resource-poor patients with HCC.

The investigators hypothesize that intervening upon key social determinants of health along with patient navigation will lead to improvements in adherence to care and timely receipt of guideline-concordant treatment among underserved patients with HCC. Specifically, the study targets three modifiable and inter-related social barriers - unreliable transportation, housing instability, and food insecurity - that have previously been shown to be prevalent among patients with cirrhosis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults (18 years or older)
  • Diagnosis of HCC (BCLC Stage A-C)
  • Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)
  • Able to provide informed consent

Exclusion Criteria

  • Non-HCC liver tumors
  • BCLC Stage D and/or Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)
  • No plans for cancer treatment for any reason including patient refusal (best supportive care only)
  • Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)
  • Incarcerated patients or pregnant patients
  • Unable to provide informed consent

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kali Zhou

Assistant Professor

University of Southern California

Study Sites (3)

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