HCC - Hepatocellular CarcinomaNCT07568457
Social Determinants of Health HCC Trial
A study testing Social Determinants of Health Program and Patient Navigation in people with HCC - Hepatocellular Carcinoma, run by University of Southern California at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Social Determinants of Health Program and Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Keck Hospital of USC
Los Angeles, California, 90033
Christopher Wong Research Coordinator, 323-452-2293, christophe.wong@med.usc.edu
LA General Medical Center
Los Angeles, California, 90033
Christopher Wong Research Coordinator, 323-452-2293, christophe.wong@med.usc.edu
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Christopher Wong Research Coordinator, 323-452-2293, christophe.wong@med.usc.edu
About this study
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
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.
Read the 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.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Social Determinants of Health Program, Patient Navigation
- Keywords
- HCC, Social Determinants of Health, SDOH, health services, interventional trial, transportation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Determinants of Health ProgramOther
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 NavigationOther
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (5)
Proportion receiving treatment
The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study
Measured: 2 years
Number of acute care visits
Utilization of acute care settings such as emergency room visits or hospital admissions during the study period
Measured: 2 years
Patient-reported outcome - FACIT-COST Survey
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)
Measured: 6 months
Patient reported outcome - FACT-HEP Survey
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)
Measured: 6 months
Mortality
Proportion of participants who are alive at end of study period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kali Zhou, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568457
- Sponsor's protocol ID
- UP-25-00802
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07568457
- Acronym / sponsor ID
- UP-25-00802
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCC, Social Determinants of Health, SDOH, health services, interventional trial, transportation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SDOH and patient navigation program | Experimental | Other: Social Determinants of Health Program, Other: Patient NavigationTransportation support through Lyft rideshares, housing support through Hyatt House LA - University Medical Center, and meal support through Project Angel Food LA |
| Patient navigation only | Active comparator | Other: Patient NavigationFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Determinants of Health ProgramSocial 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 | SDOH and patient navigation program |
| Patient NavigationUsual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc. | Other | Patient navigation only, SDOH and patient navigation program |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Determinants of Health Program and Patient Navigation in people with HCC - Hepatocellular Carcinoma, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kali Zhou (323-452-2293, kali.zhou@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with treatment uptake within 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.