Targeted Navigation in Hepatocellular Carcinoma (HCC)

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Hepatobiliary Cancer
• Interventions: Behavioral: Target Navigation Pilot Program

• Registration Number: NCT06260943
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aim 3: Targeted Navigation Pilot Program	Target Navigation Pilot Program	Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States