Clinical trial NCT06260943: Targeted Navigation in Hepatocellular Carcinoma (HCC)
Official title: Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Hepatobiliary Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The V Foundation
First posted: 2024-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of Days to First Contact
timeFrame: Up to 12 months
measure: Number of Hours for Each Contact
timeFrame: Up to 12 months
measure: Number of Days to First Appointment
timeFrame: Up to 12 months
measure: Number of Days to First Treatment
timeFrame: Up to 12 months
measure: Number of Months of Total Navigation
timeFrame: Up to 12 months
measure: Number of Participants that Die Within One Year
timeFrame: Up to 1 year
measure: Proportion of Participants Enrolled in Clinical Research
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Patricia Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: