[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07568457":3,"trial-entities:NCT07568457":121,"trial-summary:NCT07568457":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":85,"locations":88,"central_contacts":114,"overall_officials":118,"references":119,"see_also_links":120},"NCT07568457","UP-25-00802","Social Determinants of Health HCC Trial","A Randomized Controlled Interventional Trial of a Social Determinants of Health and Patient Navigation Program to Improve Treatment Utilization Among Low-income Patients With Hepatocellular Carcinoma","NOT_YET_RECRUITING","2028-09","2026-04","2026-05-05","2026-06","University of Southern California","OTHER",false,"The goal of this study is to test whether providing various social resources (transportation support through Lyft rides, housing support through Hyatt House LA, and meal support through Project Angel Food LA) will reduce treatment delays and increase treatment uptake for patients with liver cancer.","Social determinants of health (SDOH) play a central role in drop-offs at each step of the cancer care cascade for patients living in poverty. Social barriers have been shown to result in delays in care, increased non-compliance, and poorer outcomes. Importantly, negative SDOH among patients with HCC may impact receipt of therapy, a critical contributor to improved survival. Studies have shown that even small delays in therapy (more than 3 months from diagnosis) can lead to worse survival. The treatment landscape for HCC is complex, ranging from surgical options to locoregional therapies to immunotherapy, and requires multidisciplinary input from hepatologists, oncologists, interventional radiologists, and surgeons and frequent touchpoints with the healthcare system to successfully complete treatment. Social barriers can make navigating these complexities especially challenging for resource-poor patients with HCC.\n\nThe investigators hypothesize that intervening upon key social determinants of health along with patient navigation will lead to improvements in adherence to care and timely receipt of guideline-concordant treatment among underserved patients with HCC. Specifically, the study targets three modifiable and inter-related social barriers - unreliable transportation, housing instability, and food insecurity - that have previously been shown to be prevalent among patients with cirrhosis.",[19],"HCC - Hepatocellular Carcinoma",[21,22,23,24,25,26],"HCC","Social Determinants of Health","SDOH","health services","interventional trial","transportation","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[30],"NA",{"count":32,"type":33},75,"ESTIMATED",[35,40],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Social Determinants of Health Program","Social resources to be offered under our SDOH program will include 1) rideshares to treatment-related visits, 2) hotel stays for treatment-related visits, and\u002For 3) a 12-week meal delivery program.",[39],"SDOH and patient navigation program",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Patient Navigation","Usual clinic-provided patient navigation to appointments, scheduling, social resources, financial challenges, etc.",[44,39],"Patient navigation only",[46],{"measure":47,"description":48,"timeFrame":49},"Proportion of participants with treatment uptake within 90 days","The primary outcome is receipt of timely treatment for HCC defined as within 90 days of randomization","90 days",[51,55,58,62,65],{"measure":52,"description":53,"timeFrame":54},"Proportion receiving treatment","The secondary endpoint will evaluate the proportion of participants receiving treatment at any timepoint after randomization until end of study","2 years",{"measure":56,"description":57,"timeFrame":54},"Number of acute care visits","Utilization of acute care settings such as emergency room visits or hospital admissions during the study period",{"measure":59,"description":60,"timeFrame":61},"Patient-reported outcome - FACIT-COST Survey","Differences in financial toxicity as measured by the COST: A FACIT Measure of Financial Toxicity (FACIT-COST) Survey at the end of the intervention period (range 0-48; higher score means better financial well-being)","6 months",{"measure":63,"description":64,"timeFrame":61},"Patient reported outcome - FACT-HEP Survey","Comparison of difference in health-related quality of life based on the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-HEP) Survey score (range 0-180; higher score means better quality of life)",{"measure":66,"description":67,"timeFrame":54},"Mortality","Proportion of participants who are alive at end of study period","ALL","18 Years",null,{"inclusion":72,"exclusion":77,"raw_text":84},[73,74,75,76],"Adults (18 years or older)","Diagnosis of HCC (BCLC Stage A-C)","Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)","Able to provide informed consent",[78,79,80,81,82,83],"Non-HCC liver tumors","BCLC Stage D and\u002For Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)","No plans for cancer treatment for any reason including patient refusal (best supportive care only)","Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)","Incarcerated patients or pregnant patients","Unable to provide informed consent","Inclusion Criteria:\n\n* Adults (18 years or older)\n* Diagnosis of HCC (BCLC Stage A-C)\n* Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Non-HCC liver tumors\n* BCLC Stage D and\u002For Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)\n* No plans for cancer treatment for any reason including patient refusal (best supportive care only)\n* Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)\n* Incarcerated patients or pregnant patients\n* Unable to provide informed consent",[86,87],"ADULT","OLDER_ADULT",[89,104,109],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"Keck Hospital of USC","Los Angeles","California","90033","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Christopher Wong Research Coordinator","CONTACT","323-452-2293","christophe.wong@med.usc.edu",{"lat":102,"lon":103},34.05223,-118.24368,{"facility":105,"city":91,"state":92,"zip":93,"country":94,"contacts":106,"geoPoint":108},"LA General Medical Center",[107],{"name":97,"role":98,"phone":99,"email":100},{"lat":102,"lon":103},{"facility":110,"city":91,"state":92,"zip":93,"country":94,"contacts":111,"geoPoint":113},"USC Norris Comprehensive Cancer Center",[112],{"name":97,"role":98,"phone":99,"email":100},{"lat":102,"lon":103},[115],{"name":116,"role":98,"phone":99,"email":117},"Kali Zhou","kali.zhou@med.usc.edu",[],[],[],{"nct_id":4,"conditions":122,"biomarkers":124},[123],"Hepatocellular Carcinoma",[],{"nct_id":4,"found":126,"summary":127,"prompt_version":137},true,{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study with a planned enrollment of 75 participants. It is not specified if it is randomized or blinded.","completed","Social Determinants of Health Program for Liver Cancer","This study is looking at how social support can help people with a type of liver cancer called hepatocellular carcinoma (HCC). It's testing if offering rides to appointments (through Lyft), hotel stays for treatment visits (through Hyatt House LA), and meal delivery (through Project Angel Food LA) can help patients get their treatments on time. You might be able to join if you are an adult (18 or older) with HCC (stages A-C), are uninsured or have Medicaid, and are able to give informed consent. The main goal is to see how many participants start their cancer treatment within 90 days. This study is focused on improving access to care for underserved patients.","The primary endpoint is measured at 90 days, looking at treatment uptake within that timeframe.",113,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]