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โ† Trials
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Effect of the HCC Liver-Link Intervention

RecruitingNAAges 18 Years - 75 YearsAllIndiana University
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In plain words

What the trial is, and whether it could suit you

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-

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria โ€ข 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 Exclusion Criteria * 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.
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What it tests

  • Liver Link
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Where

2 sites
Indiana University School of Medicine
Indianapolis, United States
Johns Hopkins University
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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