Targeted Navigation in Hepatocellular Carcinoma (HCC)
Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation
2 other identifiers
interventional
100
1 country
1
Brief Summary
The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedStudy Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
July 15, 2025
July 1, 2025
2.5 years
February 7, 2024
July 10, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Number of Days to First Contact
The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.
Up to 12 months
Number of Hours for Each Contact
The length of time of each contact will be assessed in number of hours. Contact is defined as the length of time the navigator meets with the participant.
Up to 12 months
Number of Days to First Appointment
The time to first appointment will be assessed in number of days.
Up to 12 months
Number of Days to First Treatment
The time to first treatment will be assessed in number of days.
Up to 12 months
Number of Months of Total Navigation
The length of total navigation will be assessed in number of months.
Up to 12 months
Number of Participants that Die Within One Year
Number of participants that die within one year of enrollment in the navigation program.
Up to 1 year
Proportion of Participants Enrolled in Clinical Research
The proportion of participants enrolled in clinical research will be reported.
Up to 12 months
Study Arms (1)
Aim 3: Targeted Navigation Pilot Program
EXPERIMENTALParticipants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.
Interventions
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
You may qualify if:
- HCC Patients:
- 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.
You may not qualify if:
- Unable to speak Spanish or English
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- The V Foundationcollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Jones, MD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical Medicine
Study Record Dates
First Submitted
February 7, 2024
First Posted
February 15, 2024
Study Start
April 15, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
July 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share