Social Determinants of Health HCC Trial

NCT07568457 | Not Yet Recruiting

• 1 other identifier: UP-25-00802
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

HCC; Social Determinants of Health; SDOH; health services; interventional trial; transportation

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with treatment uptake within 90 days

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

  90 days

Secondary Outcomes (5)

• Proportion receiving treatment

  2 years

• Number of acute care visits

  2 years

• Patient-reported outcome - FACIT-COST Survey

  6 months

• Patient reported outcome - FACT-HEP Survey

  6 months

• Mortality

  2 years

Study Arms (2)

SDOH and patient navigation program

EXPERIMENTAL

Transportation support through Lyft rideshares, housing support through Hyatt House LA - University Medical Center, and meal support through Project Angel Food LA

Other: Social Determinants of Health Program; Other: Patient Navigation

Patient navigation only

ACTIVE COMPARATOR

For the duration of the intervention, patients will have access to patient navigation as per usual care. The intensity and frequency of navigation is dependent on the treating clinic; the provider of navigation (whether nurse vs social worker) is also variable by clinic. This includes: coordination of care including assistance with scheduling follow-up visits, labs, imaging, and procedures, help with filling out forms for insurance, FMLA or disability benefits, facilitating communication with treating providers, referral to community and patient support groups, providing patients with educational materials and resources, check-ins on well-being and any cancer- or treatment-related concerns

Other: Patient Navigation

Interventions

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.

SDOH and patient navigation program

Patient Navigation OTHER

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

Patient navigation only; SDOH and patient navigation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (3)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

LA General Medical Center

Los Angeles, California, 90033, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Kali Zhou

CONTACT

323-452-2293; kali.zhou@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: After informed consent and surveys have been completed, patients will be randomly assigned to one of two study arms: SDOH and patient navigation program or patient navigation only. Randomization will occur on a 2:1 ratio using the permuted block randomization method.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (3)