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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-00566 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| The V Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 3: Targeted Navigation Pilot Program | Experimental | Participants in this group will be enrolled in a Targeted Navigation Pilot Program for up to 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hours for Each Contact | 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. | Up to 12 months |
| Number of Days to First Contact | The time to first contact since hepatocellular carcinoma diagnosis will be assessed in number of days. | Up to 12 months |
| Number of Days to First Treatment | The time to first treatment will be assessed in number of days. | Up to 12 months |
| Number of Months of Total Navigation | The length of total navigation will be assessed in number of months. | Up to 12 months |
| Number of Participants that Die Within One Year | Number of participants that die within one year of enrollment in the navigation program. | Up to 1 year |
| Proportion of Participants Enrolled in Clinical Research | The proportion of participants enrolled in clinical research will be reported. | Up to 12 months |
| Acceptability | Percentage of approached individuals who agree to participate | Enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to First Appointment | The time to first appointment will be assessed in number of days. | Up to 12 months |
| Retention Rate | The number of participants still engaged in the program divided by the number still living |
Inclusion Criteria:
HCC Patients:
All other interviewees:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria Figueroa | Contact | (305) 243-0779 | gef44@med.miami.edu | |
| Patricia Jones, MD | Contact | (305) 243-0779 | pdjones@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Jones, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| From enrollment to the three months assessment |
| Feasibility of completing assessment | The proportion of participants completing the baseline assessment | From enrollment at baseline to 30 days post enrollment |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |