Targeted Navigation in Hepatocellular Carcinoma (HCC)

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06260943 · 20221220 · NCI-2024-00566

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗