Cholangiocarcinoma, Hepatobiliary Cancer, Hepatocellular Carcinoma
Conditions
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.
Interventions
BEHAVIORALTarget 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.
Sponsors
University of Miami
The V Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Contact | Up to 12 months | The time to first contact since hepatocellular carcinoma diagnosis 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. |
| Acceptability | Enrollment | Percentage of approached individuals who agree to participate |
Countries
United States
Contacts
CONTACTGloria Figueroa
CONTACTPatricia Jones, MD
PRINCIPAL_INVESTIGATORPatricia Jones, MD
University of Miami
Outcome results
None listed