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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Support Program
Indiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGTime to waitlist
Days from study enrollment to liver transplant waitlisting, assessed using OTTR.
Time frame: Up to 6 months post-enrollment
Time to resection
Days from study enrollment to surgical resection, assessed using EMR.
Time frame: Up to 6 months post-enrollment
Waitlisting or Resection
Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR
Time frame: Up to 6 months post-enrollment
Time to Death
Days from study enrollment to death, assessed using EMR and OTTR.
Time frame: Up to 6 months post-enrollment
HCC-Related Knowledge
Score on a 10-item internally developed HCC knowledge multiple-choice test.
Time frame: Baseline and 6 months post-enrollment.
Medical Mistrust
Score on 7-item Medical Mistrust Index.
Time frame: Baseline and 6 months post-enrollment.
Social Needs and AUD Linkage
Percentage of participants offered services for a social need, achieving improvement in a social need, and without alcohol use in the past 90 days; assessed by patient and social worker reports in REDCap.
Time frame: Up to 6 months post-enrollment.
Quality of Life (QOL)
Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool.
Time frame: Baseline and 6 months post-enrollment.
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