Effect of the HCC Liver-Link Intervention

NCT06728293 | Recruiting DMC

• 2 other identifiers: 236965K23MD018090
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HCC; Racial Disparities

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• HCC-Related Knowledge

  Baseline and 6 months post-enrollment.

• Medical Mistrust

  Baseline and 6 months post-enrollment.

• Social Needs and AUD Linkage

  Up to 6 months post-enrollment.

• Quality of Life (QOL)

  Baseline and 6 months post-enrollment.

Other Outcomes (6)

• Feasibility

  Ongoing through 6 months post-enrollment.

• Usability

  6 months post-enrollment.

• Satisfaction

  6 months post-enrollment.

Study Arms (2)

Liver-Link Arm

EXPERIMENTAL

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

Standard of Care Arm

NO INTERVENTION

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.

Interventions

Liver Link OTHER

Support Program

Liver-Link Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21218, United States

RECRUITING

Central Study Contacts

Savannah Yarnelle

CONTACT

(317) 278-6424; samussel@iu.edu

Regina Weber

CONTACT

(317) 278-3584; reginaw@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomized on a 1:1 basis, stratified by race and SES. NIH randomization tool will be used to randomize patients into status of care and intervention arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor | Division of Gastroenterology & Hepatology| IU School of Medicine |IU Health Associate Vice Chair of Health Equity| IU School of Medicine | IU Health

Model Details: 20 patients will then be randomized to SOC and 20 to the Liver-Link Intervention. Randomization will be stratified by race and SES.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 11, 2024
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-04

Locations

US (2)