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NCT Number: NCT07568457

Social Determinants of Health HCC Trial

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Hospital of USC, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Social Determinants of Health Program

Other

Social resources to be offered under our SDOH program will include 1) rideshares to treatment-related visits, 2) hotel stays for treatment-related visits, and/or 3) a 12-week meal delivery program.

Patient Navigation

Other

Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.

Primary outcomes

  1. Proportion of participants with treatment uptake within 90 days

    Time frame: 90 days

    The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization

Secondary outcomes

  1. Proportion receiving treatment

    Time frame: 2 years

    The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study

  2. Number of acute care visits

    Time frame: 2 years

    Utilization of acute care settings such as emergency room visits or hospital admissions during the study period

  3. Patient-reported outcome - FACIT-COST Survey

    Time frame: 6 months

    Differences in financial toxicity as measured by the COST: A FACIT Measure of Financial Toxicity (FACIT-COST) Survey at the end of the intervention period (range 0-48; higher score means better financial well-being)

  4. Patient reported outcome - FACT-HEP Survey

    Time frame: 6 months

    Comparison of difference in health-related quality of life based on the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-HEP) Survey score (range 0-180; higher score means better quality of life)

  5. Mortality

    Time frame: 2 years

    Proportion of participants who are alive at end of study period

Study contacts

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

Kali Zhou

CONTACT

[email protected]

323-452-2293

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 5, 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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