Effect of the HCC Liver-Link Intervention

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

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

Treatments tested in this trial

  • Liver Link

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

2
Indiana University School of Medicine46202, IndianapolisIndiana, United States
Johns Hopkins University21218, BaltimoreMaryland, United States

Sponsors and collaborators

Indiana University

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator