Targeted Navigation in Hepatocellular Carcinoma (HCC)

July 10, 2025 updated by: Patricia Jones, MD, University of Miami

Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Jones, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aim 3: Targeted Navigation Pilot Program
Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days to First Contact
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
The time to first appointment will be assessed in number of days.
Up to 12 months
Number of Days to First Treatment
Time Frame: Up to 12 months
The time to first treatment will be assessed in number of days.
Up to 12 months
Number of Months of Total Navigation
Time Frame: Up to 12 months
The length of total navigation will be assessed in number of months.
Up to 12 months
Number of Participants that Die Within One Year
Time Frame: Up to 1 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
Time Frame: Up to 12 months
The proportion of participants enrolled in clinical research will be reported.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

The V Foundation

Investigators

  • Principal Investigator: Patricia Jones, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221220
  • NCI-2024-00566 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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