Targeted Navigation in Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260943
• Other study ID #: 20221220
• Secondary ID: NCI-2024-00566
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Gloria Figueroa
• Phone: (305) 243-0779
• Email: gef44[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatobiliary Cancer
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The V Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days to First Contact	The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.	Up to 12 months
Primary	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.	Up to 12 months
Primary	Number of Days to First Appointment	The time to first appointment will be assessed in number of days.	Up to 12 months
Primary	Number of Days to First Treatment	The time to first treatment will be assessed in number of days.	Up to 12 months
Primary	Number of Months of Total Navigation	The length of total navigation will be assessed in number of months.	Up to 12 months
Primary	Number of Participants that Die Within One Year	Number of participants that die within one year of enrollment in the navigation program.	Up to 1 year
Primary	Proportion of Participants Enrolled in Clinical Research	The proportion of participants enrolled in clinical research will be reported.	Up to 12 months