Targeted Navigation in Hepatocellular Carcinoma (HCC)

University of Miami100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Hepatocellular Carcinoma Cholangiocarcinoma Hepatobiliary Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 months

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 months

Number of Days to First Appointment

The time to first appointment will be assessed in number of days.

Time frame: Up to 12 months

Number of Days to First Treatment

The time to first treatment will be assessed in number of days.

Time frame: Up to 12 months

Number of Months of Total Navigation

The length of total navigation will be assessed in number of months.

Time frame: Up to 12 months

Number of Participants that Die Within One Year

Number of participants that die within one year of enrollment in the navigation program.

Time frame: Up to 1 year

Proportion of Participants Enrolled in Clinical Research

The proportion of participants enrolled in clinical research will be reported.

Time frame: Up to 12 months

Central Contacts

Gloria Figueroa

CONTACT

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

Patricia Jones, MD

CONTACT

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

Targeted Navigation in Hepatocellular Carcinoma (HCC)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts