Effect of the HCC Liver-Link Intervention
Indiana University
40 participants
Jun 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria16
- • 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 Criteria9
- 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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Interventions
Support Program
Locations(2)
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NCT06728293