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Recruiting

NCT Number: NCT06260943

Targeted Navigation in Hepatocellular Carcinoma (HCC)

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.

Recruiting

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Hepatobiliary Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target Navigation Pilot Program

Behavioral

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 outcomes

  1. Number of Hours for Each Contact

    Time frame: 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.

  2. Number of Days to First Contact

    Time frame: Up to 12 months

    The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days.

  3. Number of Days to First Treatment

    Time frame: Up to 12 months

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

  4. Number of Months of Total Navigation

    Time frame: Up to 12 months

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

  5. Number of Participants that Die Within One Year

    Time frame: Up to 1 year

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

  6. Proportion of Participants Enrolled in Clinical Research

    Time frame: Up to 12 months

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

  7. Acceptability

    Time frame: Enrollment

    Percentage of approached individuals who agree to participate

Other outcomes

  1. Number of Days to First Appointment

    Time frame: Up to 12 months

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

  2. Retention Rate

    Time frame: From enrollment to the three months assessment

    The number of participants still engaged in the program divided by the number still living

  3. Feasibility of completing assessment

    Time frame: From enrollment at baseline to 30 days post enrollment

    The proportion of participants completing the baseline assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Figueroa

CONTACT

[email protected]

(305) 243-0779

Patricia Jones, MD

CONTACT

[email protected]

(305) 243-0779

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The V Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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