Targeted Navigation in Hepatocellular Carcinoma (HCC)

University of Miami

Status: Enrolling

Conditions: Hepatobiliary Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma

Treatments: Behavioral: Target Navigation Pilot Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06260943

20221220

NCI-2024-00566 (Registry Identifier)

Details and patient eligibility

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. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Aim 3: Targeted Navigation Pilot Program

Experimental group

Description:

Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.

Treatment:

Behavioral: Target Navigation Pilot Program