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Recruiting NCT06260943

Targeted Navigation in Hepatocellular Carcinoma (HCC)

No phase Interventional Hepatocellular Carcinoma Cholangiocarcinoma Hepatobiliary Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Target Navigation Pilot Program.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Cholangiocarcinoma, Hepatobiliary Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Number of Hours for Each Contact [Time frame: Up to 12 months]
  • Number of Days to First Contact [Time frame: Up to 12 months]
  • Number of Days to First Treatment [Time frame: Up to 12 months]
  • Number of Months of Total Navigation [Time frame: Up to 12 months]
  • Number of Participants that Die Within One Year [Time frame: Up to 1 year]
  • Proportion of Participants Enrolled in Clinical Research [Time frame: Up to 12 months]
  • Acceptability [Time frame: Enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06260943 · 20221220 · NCI-2024-00566

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗