Health TrialsbyHealthPanel

Social Determinants of Health HCC Trial

ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Social Determinants of Health Program

    Other intervention

    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 intervention

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: SDOH and patient navigation programExperimental treatment 2 interventions
Group B: Patient navigation onlyActive comparator 1 intervention

Trial outcomes

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

Time frame
90 days

Secondary outcomes

1

Proportion receiving treatment

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

Time frame
2 years
2

Number of acute care visits

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

Time frame
2 years
3

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)

Time frame
6 months
4

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)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: