Effect of the HCC Liver-Link Intervention

ConditionsHCC Racial Disparities

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Liver Link
Other intervention
Support Program

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Liver-Link ArmExperimental treatment 1 intervention

Group B: Standard of Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Time 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

Secondary outcomes

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.

Other outcomes

Study Feasibility

Consent rate, reasons for decline, and percentage of visit completion (enrollment, support, social work), assessed in REDCap.

Time frame

Ongoing through 6 months post-enrollment.

Usability

Score on the Modified System Usability Scale assessing intervention binder.

Time frame

6 months post-enrollment.

Study Satisfaction

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

Time frame

6 months post-enrollment.

Fidelity

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

Time frame

6 months post-enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov

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