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Social Determinants of Health HCC Trial

30. april 2026 oppdatert av: Kali Zhou, University of Southern California

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90033
        • USC Norris Comprehensive Cancer Center
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90033
        • Keck Hospital of USC
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90033
        • LA General Medical Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Annen: Social 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.
Annen: Patient Navigation
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
Annen: Patient Navigation
Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants with treatment uptake within 90 days
Tidsramme: 90 days
The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization
90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion receiving treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 years
Proportion of participants who are alive at end of study period
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Southern California

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

13. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UP-25-00802

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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