Targeted Navigation in Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Target Navigation Pilot Program
BehavioralParticipants 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.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Aim 3: Targeted Navigation Pilot ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 months2
Number of Days to First Contact
The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.
Time frame
Up to 12 months3
Number of Days to First Treatment
The time to first treatment will be assessed in number of days.
Time frame
Up to 12 months4
Number of Months of Total Navigation
The length of total navigation will be assessed in number of months.
Time frame
Up to 12 monthsOther outcomes
1
Number of Days to First Appointment
The time to first appointment will be assessed in number of days.
Time frame
Up to 12 months2
Retention Rate
The number of participants still engaged in the program divided by the number still living
Time frame
From enrollment to the three months assessment3
Feasibility of completing assessment
The proportion of participants completing the baseline assessment
Time frame
From enrollment at baseline to 30 days post enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
The V Foundation
Collaborator
Source ClinicalTrials.gov