Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-04-15
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Aim 3: Targeted Navigation Pilot Program
Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.
Target Navigation Pilot Program
Participants will meet with a navigator, in either English, Spanish or Creole, biweekly, in person or virtually, until the first treatment appointment and every three months after. Each session will last approximately one hour; depending on the needs identified, patients will be connected to appropriate institutional or community-based resources.
Interventions
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Target Navigation Pilot Program
Participants will meet with a navigator, in either English, Spanish or Creole, biweekly, in person or virtually, until the first treatment appointment and every three months after. Each session will last approximately one hour; depending on the needs identified, patients will be connected to appropriate institutional or community-based resources.
Eligibility Criteria
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Inclusion Criteria
* Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.
* Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0.
* Adults, age 18 or older
* Able to provide informed consent
* All other interviewees:
* Advocates who will self-identify as having had HCC.
* Others who self-identify as either a caregiver or support person of an HCC patient.
Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.
Exclusion Criteria
* West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.
* Adults unable or unwilling to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected
18 Years
ALL
Yes
Sponsors
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The V Foundation
OTHER
University of Miami
OTHER
Responsible Party
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Patricia Jones, MD
Associate Professor of Clinical Medicine
Principal Investigators
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Patricia Jones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-00566
Identifier Type: REGISTRY
Identifier Source: secondary_id
20221220
Identifier Type: -
Identifier Source: org_study_id
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