Clinical trial NCT06728293: Effect of the HCC Liver-Link Intervention
Official title: Effect of the HCC Liver-Link Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HCC
Racial Disparities
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief summary: Mortality rates for hepatocellular carcinoma (HCC) have risen in the US over the past two decades, disproportionately impacting Black patients with chronic liver disease5,6. Black patients are 50% less likely than White patients to receive curative therapies for HCC even when presenting with early stage disease7,8. Reasons for disparities in mortality are in part related to failure to progress through the complex HCC care continuum to access curative therapies as a result of the unequal distribution of social and structural determinants of health (SSDOH)9,10. SSDOH are the social conditions that influence individual and group differences in health11. For example, investigators found that Black patients with early stage HCC were more likely than White patients to have ongoing alcohol and substance and as a result were not candidates for liver transplantation (LT)7. In addition, data from our prospective cohort study demonstrated that Black patients with HCC have a higher burden of poor SSDOH that than their White counterparts, including higher rates of poverty, educational achievement less than high school and lapses in subspecialty care. The downstream consequences of these inequities including poor health-related knowledge and social needs are being increasingly targeted for improvement by hospital systems and providers in cancer care. However, there are currently no interventions designed to target social determinants or downstream social needs and eliminate racial disparities in HCC care.

Successful health disparities interventions have been culturally tailored and multi-level12. Therefore, an intervention that successfully reduces disparities in HCC outcomes should have these characteristics and address both patient- and system-level SSDOH. The HCC Liver-Link intervention investigators propose to develop is designed to: a) improve patients' HCC-related disease and treatment knowledge; b) screen patients for social needs and substance use and refer to social work for linkage to local services; and c) use our multidisciplinary HCC tumor board to facilitate linkage to subspecialty HCC cancer care.

Earlier portions of this research project were devoted to developing the education program component of the HCC Liver-Link intervention. This intervention, a full multi-level intervention designed to address patient- and system-level SSDOH variables and facilitate access to curative HCC therapies (liver transplantation and resection) in a cohort of Black patients with Barcelona Clinic Liver Cancer prognosis stage 0, A and downstaged B disease underwent pilot testing in a previous project. The aims of this portion of the study are to estimate the effect of the HCC Liver-Link intervention on the time to receipt of curative therapies and HCC related knowledge in black patients with HCC. Toward that end, investigators will conduct a multi-center, pilot randomized controlled trial to test the multi-level intervention in 40 black BCLC 0, A or downstaged B disease patients who will be followed for 6 months or until waitlisted for liver transplant.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18-75 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Self-reported Black race 4 Self-reported insured by Medicare

5. Self-reported unmarried 6. Anyone within UCSF criteria

Exclusion Criteria:

1. Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.
2. Age over 75
3. EF\<40%
4. BMI over 50
5. 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.
6. Prior history of any solid organ transplant.
7. History of advanced malignancies other than hepatocellular carcinoma

Primary outcomes:
measure: HCC-related knowledge via the HCC Curative Therapies Knowledge Test Scores
timeFrame: Day 0, 3 and 6 months
measure: Quality of Life Domains (anxiety, depression, sleep, participation in social roles, pain)
timeFrame: Day 0 and 6 months
measure: waitlisting or resection
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility and usability of intervention
timeFrame: 6 months
measure: Satisfaction and acceptibility of intervention with modified CSQ-8
timeFrame: 6 months
measure: Time of Death
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: