Social Determinants of Health HCC Trial

Official 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

Overview

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.

Interventions

• Other Social Determinants of Health Program
  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.
• Other Patient Navigation
  Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.

Primary outcome measures

• Proportion of participants with treatment uptake within 90 days [Time frame: 90 days]

Secondary outcome measures (5)

• Proportion receiving treatment [Time frame: 2 years]
• Number of acute care visits [Time frame: 2 years]
• Patient-reported outcome - FACIT-COST Survey [Time frame: 6 months]
• Patient reported outcome - FACT-HEP Survey [Time frame: 6 months]
• Mortality [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 3 centers

• Keck Hospital of USC — Los Angeles
• LA General Medical Center — Los Angeles
• USC Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT07568457 · UP-25-00802

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗