Effect of the HCC Liver-Link Intervention

June 3, 2026 updated by: Lauren Nephew, Indiana University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Aly T Strauss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to waitlist
Time Frame: Up to 6 months post-enrollment
Days from study enrollment to liver transplant waitlisting, assessed using OTTR.
Up to 6 months post-enrollment
Time to resection
Time Frame: Up to 6 months post-enrollment
Days from study enrollment to surgical resection, assessed using EMR.
Up to 6 months post-enrollment
Waitlisting or Resection
Time Frame: Up to 6 months post-enrollment
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
Time Frame: Up to 6 months post-enrollment
Days from study enrollment to death, assessed using EMR and OTTR.
Up to 6 months post-enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HCC-Related Knowledge
Time Frame: Baseline and 6 months post-enrollment.
Score on a 10-item internally developed HCC knowledge multiple-choice test.
Baseline and 6 months post-enrollment.
Medical Mistrust
Time Frame: Baseline and 6 months post-enrollment.
Score on 7-item Medical Mistrust Index.
Baseline and 6 months post-enrollment.
Social Needs and AUD Linkage
Time Frame: Up to 6 months post-enrollment.
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)
Time Frame: Baseline and 6 months post-enrollment.
Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool.
Baseline and 6 months post-enrollment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: 6 months post-enrollment.
Score on the Modified System Usability Scale assessing intervention binder.
6 months post-enrollment.
Fidelity
Time Frame: 6 months post-enrollment
Percentage of scripted social support group content delivered across sites, assessed via transcript comparison.
6 months post-enrollment
Intervention Feedback - Patients
Time Frame: 6 months post-enrollment.
Open-ended survey of patient satisfaction with support group content, binder content, and social work.
6 months post-enrollment.
Intervention Feedback - Providers
Time Frame: 6 months post-enrollment.
Open-ended survey assessing provider satisfaction with patient study participation and implementation of recommendations regarding social needs.
6 months post-enrollment.
Study Feasibility
Time Frame: Ongoing through 6 months post-enrollment.
Consent rate, reasons for decline, and percentage of visit completion (enrollment, support, social work), assessed in REDCap.
Ongoing through 6 months post-enrollment.
Study Satisfaction
Time Frame: 6 months post-enrollment.
Score on the Client Satisfaction Questionnaire (CSQ-8; range 25-100).
6 months post-enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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