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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion receiving treatment | The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study | 2 years |
| Number of acute care visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kali Zhou | Contact | 323-452-2293 | kali.zhou@med.usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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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.
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| Patient Navigation | Other | Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc. |
|
Utilization of acute care settings such as emergency room visits or hospital admissions during the study period
| 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) | 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) | 6 months |
| Mortality | Proportion of participants who are alive at end of study period | 2 years |
| LA General Medical Center | Los Angeles | California | 90033 | United States |
|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006298 | Health Services Administration |