Liver Link
OtherSupport Program
NCT Number: NCT06728293
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Indiana University School of Medicine, Indianapolis, Indiana, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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:
Exclusion criteria
Support Program
Time frame: Up to 6 months post-enrollment
Days from study enrollment to liver transplant waitlisting, assessed using OTTR.
Time frame: Up to 6 months post-enrollment
Days from study enrollment to surgical resection, assessed using EMR.
Time frame: Up to 6 months post-enrollment
Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR
Time frame: Up to 6 months post-enrollment
Days from study enrollment to death, assessed using EMR and OTTR.
Time frame: Baseline and 6 months post-enrollment.
Score on a 10-item internally developed HCC knowledge multiple-choice test.
Time frame: Baseline and 6 months post-enrollment.
Score on 7-item Medical Mistrust Index.
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.
Time frame: Baseline and 6 months post-enrollment.
Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool.
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.
Time frame: 6 months post-enrollment.
Score on the Modified System Usability Scale assessing intervention binder.
Time frame: 6 months post-enrollment.
Score on the Client Satisfaction Questionnaire (CSQ-8; range 25-100).
Time frame: 6 months post-enrollment
Percentage of scripted social support group content delivered across sites, assessed via transcript comparison.
Time frame: 6 months post-enrollment.
Open-ended survey of patient satisfaction with support group content, binder content, and social work.
Time frame: 6 months post-enrollment.
Open-ended survey assessing provider satisfaction with patient study participation and implementation of recommendations regarding social needs.
Contact information is provided by the study sponsor or research team.
Regina Weber
CONTACT
Savannah Yarnelle
CONTACT
Indiana University
Other
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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