NCT06260943 · University of Miami
Targeted Navigation in Hepatocellular Carcinoma (HCC)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
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.
Number of Days to First Treatment
Time frame: Up to 12 months
The time to first treatment will be assessed in number of days.
Number of Months of Total Navigation
Time frame: Up to 12 months
The length of total navigation will be assessed in number of 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.
Proportion of Participants Enrolled in Clinical Research
Time frame: Up to 12 months
The proportion of participants enrolled in clinical research will be reported.
Acceptability
Time frame: Enrollment
Percentage of approached individuals who agree to participate
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Miami, Florida
Collaborators
The V Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations