HCC, Racial Disparities
Conditions
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.
Interventions
OTHERLiver Link
Support Program
Sponsors
Indiana University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
20 patients will then be randomized to SOC and 20 to the Liver-Link Intervention. Randomization will be stratified by race and SES.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• 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 * Unmarried
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to waitlist | Up to 6 months post-enrollment | Days from study enrollment to liver transplant waitlisting, assessed using OTTR. |
| Time to resection | Up to 6 months post-enrollment | Days from study enrollment to surgical resection, assessed using EMR. |
| Waitlisting or Resection | Up to 6 months post-enrollment | Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR |
| Time to Death | Up to 6 months post-enrollment | Days from study enrollment to death, assessed using EMR and OTTR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCC-Related Knowledge | Baseline and 6 months post-enrollment. | Score on a 10-item internally developed HCC knowledge multiple-choice test. |
| Medical Mistrust | Baseline and 6 months post-enrollment. | Score on 7-item Medical Mistrust Index. |
| Social Needs and AUD Linkage | 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. |
| Quality of Life (QOL) | Baseline and 6 months post-enrollment. | Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool. |
Countries
United States
Contacts
CONTACTSavannah Yarnelle
CONTACTRegina Weber
Outcome results
None listed