Social Determinants of Health HCC Trial
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kali Zhou
- Telefonnummer: 323-452-2293
- E-post: kali.zhou@med.usc.edu
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90033
- USC Norris Comprehensive Cancer Center
-
Kontakt:
- Christopher Wong Research Coordinator
- Telefonnummer: 323-452-2293
- E-post: christophe.wong@med.usc.edu
-
Los Angeles, California, Förenta staterna, 90033
- Keck Hospital of USC
-
Kontakt:
- Christopher Wong Research Coordinator
- Telefonnummer: 323-452-2293
- E-post: christophe.wong@med.usc.edu
-
Los Angeles, California, Förenta staterna, 90033
- LA General Medical Center
-
Kontakt:
- Christopher Wong Research Coordinator
- Telefonnummer: 323-452-2293
- E-post: christophe.wong@med.usc.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: SDOH and patient navigation program
Transportation support through Lyft rideshares, housing support through Hyatt House LA - University Medical Center, and meal support through Project Angel Food LA
|
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.
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
|
|
Aktiv komparator: Patient navigation only
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
|
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants with treatment uptake within 90 days
Tidsram: 90 days
|
The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization
|
90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion receiving treatment
Tidsram: 2 years
|
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
Tidsram: 2 years
|
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
Tidsram: 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)
|
6 months
|
|
Patient reported outcome - FACT-HEP Survey
Tidsram: 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)
|
6 months
|
|
Mortality
Tidsram: 2 years
|
Proportion of participants who are alive at end of study period
|
2 years
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Neoplasmer i levern
- Carcinom
- Karcinom, hepatocellulärt
- Administration
- Patientvårdshantering
- Omfattande vård
- Patientcentrerad vård
- Grundvård
- Patientnavigering
Andra studie-ID-nummer
- UP-25-00802
Läkemedels- och apparatinformation, studiedokument
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