Effect of the HCC Liver-Link Intervention

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 Overview

• Status: Recruiting
• Conditions: HCC; Racial Disparities
• Intervention / Treatment: Other: Liver Link

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savannah Yarnelle; Phone Number: (317) 278-6424; Email: samussel@iu.edu
• Study Contact Backup: Name: Regina Weber; Phone Number: (317) 278-3584; Email: reginaw@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
      • Principal Investigator: Lauren Nephew, MD
      • Contact: Nicole Garcia; Phone Number: 317-287-0411; Email: garcini@iu.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins University
      • Contact: Aly T Strauss, MD; Phone Number: 410-614-1982; Email: astraus6@jhmi.edu
      • Principal Investigator: Aly T Strauss, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liver-Link Arm; Those randomized to the Liver-Link portion of the study will proceed through the Liver-Link component intervention. Participation in this study will last 6 months. Participants in this group are assessed for knowledge of their disease, quality of life, substance use, and for social needs at the beginning of the program. Those who screen positive for social needs or high-risk alcohol will see social work. Participants will attend 3 support groups and compelte exit surveys. Participants will have 3 milestone checks during the 6 month study period and will be referred back to social work if they do not meet milestones. Participants will also have a knowledge assessment after a total of 2 HCC-related visits.	Other: Liver Link; Support Program
No Intervention: Standard of Care Arm; Individuals in the standard of care portion of the study will complete several questionnaires at the enrollment visit . Over the duration of study participation (6 months), participants in this arm may meet with a social worker as part of their standard health care treatment and will receive education via these standard of care visits. After at least two visits related to HCC clinical care, and participants in this arm will be contacted and will be asked to complete the knowledge assessment tool. At tne end of study they will complete exit survieys via redcap or phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to waitlist	Days from study enrollment to liver transplant waitlisting, assessed using OTTR.	Up to 6 months post-enrollment
Time to resection	Days from study enrollment to surgical resection, assessed using EMR.	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	Up to 6 months post-enrollment
Time to Death	Days from study enrollment to death, assessed using EMR and OTTR.	Up to 12 months post-enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC-Related Knowledge	Score on a 10-item internally developed HCC knowledge multiple-choice test.	Baseline and 6 months post-enrollment.
Medical Mistrust	Score on 7-item Medical Mistrust Index.	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.	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.	Baseline and 6 months post-enrollment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Consent rate, reasons for decline, and percentage of visit completion (enrollment, support, social work), assessed in REDCap.	Ongoing through 6 months post-enrollment.
Usability	Score on the Modified System Usability Scale assessing intervention binder.	6 months post-enrollment.
Satisfaction	Score on the Client Satisfaction Questionnaire (CSQ-8; range 25-100).	6 months post-enrollment.
Fidelity	Percentage of scripted social support group content delivered across sites, assessed via transcript comparison.	6 months post-enrollment
Intervention Feedback - Patients	Open-ended survey of patient satisfaction with support group content, binder content, and social work.	6 months post-enrollment.
Intervention Feedback - Providers	Open-ended survey assessing provider satisfaction with patient study participation and implementation of recommendations regarding social needs.	6 months post-enrollment.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23696; 5K23MD018090 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No