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 groupsSponsors and collaborators
Indiana University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov