Liver Link Intervention for Liver Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for Black patients with early-stage liver cancer (Hepatocellular Carcinoma) who have not yet received curative therapies. It aims to address racial disparities in healthcare by helping patients navigate the healthcare system and improve their knowledge about their disease and treatment options.

Inclusion Criteria

Ability to provide written informed consent and HIPAA authorization

Anyone within UCSF criteria

Self-reported Black race

+3 more

Exclusion Criteria

EF<40%

I am not considered a candidate for liver surgery or transplant according to my doctor.

My BMI is over 50.

+4 more

Participant Groups

The 'Liver Link' intervention is being tested to see if it can reduce the time it takes for Black patients with liver cancer to receive curative treatments. It includes education, screening for social needs and substance use, and coordination with a tumor board to connect patients to specialized care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Liver-Link ArmExperimental Treatment1 Intervention

Those randomized to the Liver-Link portion of the study will proceed through the Liver-Link component intervention. Participation in this study will last 6 months. Participants in this group are assessed for knowledge of their disease, quality of life, substance use, and for social needs at the beginning of the program. Those who screen positive for social needs or high-risk alcohol will see social work. Participants will attend 3 support groups and compelte exit surveys. Participants will have 3 milestone checks during the 6 month study period and will be referred back to social work if they do not meet milestones. Participants will also have a knowledge assessment after a total of 2 HCC-related visits.

Group II: Standard of Care ArmActive Control1 Intervention

Individuals in the standard of care portion of the study will complete several questionnaires at the enrollment visit . Over the duration of study participation (6 months), participants in this arm may meet with a social worker as part of their standard health care treatment and will receive education via these standard of care visits. After at least two visits related to HCC clinical care, and participants in this arm will be contacted and will be asked to complete the knowledge assessment tool. At tne end of study they will complete exit survieys via redcap or phone.