Effect of the HCC Liver-Link Intervention

Обзор

This study is a pilot, multi-center randomized controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care. The intervention combines: (1) patient education to improve HCC-related disease and treatment knowledge, (2) social needs and substance use screening with referral to social work and community resources, and (3) facilitated access to subspecialty cancer care through a multidisciplinary HCC tumor board. A total of 40 Black patients with Barcelona Clinic Liver Cancer (BCLC) stage 0, A, or downstaged B disease will be randomized to receive either the HCC Liver-Link intervention or usual care and followed for 6 months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform development of larger interventions to eliminate racial disparities in HCC outcomes.

Вмешательства

• Другое Liver Link
  Support Program

Первичные конечные точки

• Time to waitlist [Срок оценки: Up to 6 months post-enrollment]
• Time to resection [Срок оценки: Up to 6 months post-enrollment]
• Waitlisting or Resection [Срок оценки: Up to 6 months post-enrollment]
• Time to Death [Срок оценки: Up to 6 months post-enrollment]

Вторичные конечные точки (4)

• HCC-Related Knowledge [Срок оценки: Baseline and 6 months post-enrollment.]
• Medical Mistrust [Срок оценки: Baseline and 6 months post-enrollment.]
• Social Needs and AUD Linkage [Срок оценки: Up to 6 months post-enrollment.]
• Quality of Life (QOL) [Срок оценки: Baseline and 6 months post-enrollment.]

Критерии участия

Критерии включения

• Within UCSF criteria:

Candidates are eligible or a standardized MELD or PELD exception if, before completing locoregional therapy, they have lesions that meet one of the following criteria:

• One Class 5 lesion greater than 5 cm and less than or equal to 8 cm
• two or three Class 5 lesions that meeting all of the following

• At least one lesion greater than 3cm
• Each lesion less than or equal to 5 cm, and
• A total diameter of all lesions less than or equal to 8cm
• Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.
• Between 18-75 years old
• Have no more than two visits with an HCC-related provider
• Able to read, write, and speak English
• Any 1 of the following:

• Self-report as Black race (can be multiple races as long as 1 is Black)
• Self-report as insured by Medicaid (+/- Medicare)
• SVI (Social vulnerability index) >= .75
• Unmarried

Критерии исключения

• Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.
• Age over 75
• Last transthoracic echocardiogram with EF<40% (OK if no prior echo)
• BMI over 50
• Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented
• Prior history of any solid organ transplant
• Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)
• Patients who have undergone resection or waitlisted
• Patients near completion of transplant evaluation, PI to determine utility of intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Indiana University School of Medicine — Indianapolis
• Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT06728293 · 23696 · 5K23MD018090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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