To hear about similar clinical trials, please enter your email below
Trial Title:
Targeted Navigation in Hepatocellular Carcinoma (HCC)
NCT ID:
NCT06260943
Condition:
Hepatocellular Carcinoma
Cholangiocarcinoma
Hepatobiliary Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Cholangiocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Target Navigation Pilot Program
Description:
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.
Arm group label:
Aim 3: Targeted Navigation Pilot Program
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gloria Figueroa
Phone:
(305) 243-0779
Email:
gef44@med.miami.edu
Contact backup:
Last name:
Patricia Jones, MD
Phone:
(305) 243-0779
Email:
pdjones@med.miami.edu
Contact backup:
Last name:
Patricia Jones, MD
Start date:
April 15, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
The V Foundation
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06260943
