Recruiting

Targeted Navigation

Sponsor:

University of Miami

Code:

NCT06260943

Conditions

Hepatocellular Carcinoma

Cholangiocarcinoma

Hepatobiliary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Target Navigation Pilot Program

Study Details

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.

Conditions

Hepatocellular Carcinoma

Cholangiocarcinoma

Hepatobiliary Cancer

Study ID

NCT06260943

Start date

Apr 15, 2024

Status verified date

Jun, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Number of Hours for Each Contact [ Time Frame: Up to 12 months ]
  • Number of Days to First Contact [ Time Frame: Up to 12 months ]
  • Number of Days to First Treatment [ Time Frame: Up to 12 months ]
  • Number of Months of Total Navigation [ Time Frame: Up to 12 months ]
  • Number of Participants that Die Within One Year [ Time Frame: Up to 1 year ]
  • Proportion of Participants Enrolled in Clinical Research [ Time Frame: Up to 12 months ]
  • Acceptability [ Time Frame: Enrollment ]

Central Contacts and Locations

Central contacts

Gloria Figueroa

(305) 243-0779gef44@med.miami.edu

Patricia Jones, MD

(305) 243-0779pdjones@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Gloria Figueroa

(305) 243-0779gef44@med.miami.edu

Patricia Jones, MD

(305) 243-0779pdjones@med.miami.edu

Principal Investigator:

Patricia Jones, MD

More Information

Sponsor

University of Miami

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-02.