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NCT Number: NCT06728293

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.

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver Link

Other

Support Program

Primary outcomes

  1. Time to waitlist

    Time frame: Up to 6 months post-enrollment

    Days from study enrollment to liver transplant waitlisting, assessed using OTTR.

  2. Time to resection

    Time frame: Up to 6 months post-enrollment

    Days from study enrollment to surgical resection, assessed using EMR.

  3. 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

  4. Time to Death

    Time frame: Up to 6 months post-enrollment

    Days from study enrollment to death, assessed using EMR and OTTR.

Secondary outcomes

  1. HCC-Related Knowledge

    Time frame: Baseline and 6 months post-enrollment.

    Score on a 10-item internally developed HCC knowledge multiple-choice test.

  2. Medical Mistrust

    Time frame: Baseline and 6 months post-enrollment.

    Score on 7-item Medical Mistrust Index.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. Usability

    Time frame: 6 months post-enrollment.

    Score on the Modified System Usability Scale assessing intervention binder.

  3. Study Satisfaction

    Time frame: 6 months post-enrollment.

    Score on the Client Satisfaction Questionnaire (CSQ-8; range 25-100).

  4. Fidelity

    Time frame: 6 months post-enrollment

    Percentage of scripted social support group content delivered across sites, assessed via transcript comparison.

  5. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Regina Weber

CONTACT

[email protected]

(317) 278-3584

Savannah Yarnelle

CONTACT

[email protected]

(317) 278-6424

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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