Effect of the HCC Liver-Link Intervention

Overview

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.

Interventions

• Other Liver Link
  Support Program

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

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

Identifiers

NCT: NCT06728293 · 23696 · 5K23MD018090

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗