HCC - Hepatocellular Carcinoma
Conditions
Keywords
HCC, Social Determinants of Health, SDOH, health services, interventional trial, transportation
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.
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
OTHERSocial 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.
OTHERPatient Navigation
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with treatment uptake within 90 days | 90 days | The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion receiving treatment | 2 years | The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study |
| Number of acute care visits | 2 years | Utilization of acute care settings such as emergency room visits or hospital admissions during the study period |
| Patient-reported outcome - FACIT-COST Survey | 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) |
| Patient reported outcome - FACT-HEP Survey | 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) |
| Mortality | 2 years | Proportion of participants who are alive at end of study period |
Countries
United States
Contacts
CONTACTKali Zhou
Outcome results
None listed