[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653592":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":43,"armGroups":47,"interventions":56,"overallOfficials":60,"centralContacts":64,"locations":74,"responsibleParty":88,"collaborators":43,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":43,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":43,"enrollmentInfo":100,"targetDuration":43,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":114,"whyStopped":43,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of California, Irvine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Emergency department visits, hospitalizations, and urgent care visits","Detailed information regarding emergency department visits, hospitalization, and urgent care visits from the first 3 months of anticancer treatment (after joining the study) will be obtained using electronic medical records, and the UCI Health Data Warehouse.","baseline and 3 months post-baseline",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Health-related quality of life","Quality of life will be measured Patient-Reported Outcomes Measurement Information System Global Health (PROMIS Global Health), a 10-item Likert scale (questions 1-8 and 10 on a 5-point scale and question 9 on an 11-point scale) instrument yielding two scores, physical health and mental health, where higher scores indicate better health.",{"measure":18,"description":19,"timeFrame":12},"Symptom severity","Symptom severity will be assessed by the Edmonton Symptom Assessment System (ESAS), an 11-point Likert scale (0-10) that measures symptom intensity. A change of at least one point is considered clinically meaningful, with higher scores indicating greater symptom burden.",{"measure":21,"description":22,"timeFrame":12},"Health literacy","Health literacy will be assessed using the Brief Health Literacy Screening (BHLS) tool, with each item rated on a 5-point scale from 1 to 5, yielding a total score ranging from 3 to 15. Higher scores indicate better health literacy.",[24,27,31,34,37],{"measure":25,"description":26,"timeFrame":12},"C-Reactive Protein (CRP) Level","Dried blood spot (DBS) sampling will be used to collect and analyze CRP level (mg\u002FL)",{"measure":28,"description":29,"timeFrame":30},"Interleukin-1 Receptor Antagonist (IL-1RA) Level","Dried blood spot (DBS) sampling will be used to collect and analyze IL-1RA level (pg\u002FmL)","Baseline and 3 months post-baseline",{"measure":32,"description":33,"timeFrame":30},"Interleukin-6 (IL-6) Level","Dried blood spot (DBS) sampling will be used to collect and analyze IL-6 level (pg\u002FmL)",{"measure":35,"description":36,"timeFrame":30},"Tumor Necrosis Factor-alpha (TNF-α) Level","Dried blood spot (DBS) sampling will be used to collect and analyze TNF-α level (pg\u002FmL)",{"measure":38,"description":39,"timeFrame":30},"TNF Receptor Type II (TNF-RII) Level","Dried blood spot (DBS) sampling will be used to collect and analyze TNF-RII level (pg\u002FmL)",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":46,"maskingDescription":43,"whoMasked":43},"NONE",[48,51],{"label":49,"type":50,"description":43,"interventionNames":43},"Usual care","NO_INTERVENTION",{"label":52,"type":53,"description":43,"interventionNames":54},"Patient-Reported Outcomes (PRO)-driven supportive care navigation","EXPERIMENTAL",[55],"Other: Patient-Reported Outcomes (PRO)-driven supportive care navigation",[57],{"type":6,"name":52,"description":58,"armGroupLabels":59,"otherNames":43},"Patients within the intervention arm will receive ePRO-driven supportive care navigation consisting of: (1) routine distress screening and care needs assessment; (2) machine learning-based acute care utilization risk prediction; (3) culturally grounded supportive care navigation; and (4) community follow-up.",[52],[61],{"name":62,"affiliation":5,"role":63},"Alexandre Chan, PharmD, PhD, MPH","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":43,"email":69},"Fan-Ying Chan, MS","CONTACT","949-738-7135","fanyinc@uci.edu",{"name":71,"role":67,"phone":72,"phoneExt":43,"email":73},"Matthew Heshmatipour, MPH","9494624610","mheshmat@hs.uci.edu",[75],{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":43},"Chao Family Comprehensive Cancer Center","Irvine","California","92617","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-117.82311,33.66946,{"lat":86,"lon":85},{"type":63,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Alexandre Chan","Professor of Clinical Pharmacy","100653592","a-randomized-controlled-trial-to-compare-the-effectiveness-of-a-patient-reported-outcomes-driven-supportive-care-navigation-among-hispaniclatinx-cancer-patients-100653592",false,"NCT07787806","Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic\u002FLatinx Cancer Patients","A Randomized Controlled, Type 1 Hybrid Effectiveness-implementation Trial Study to Compare the Effectiveness of a Patient-Reported Outcomes (PRO)-Driven Culturally Grounded Supportive Care Navigation in Reducing Healthcare Disparities Among Hispanic\u002FLatinx Patients Receiving Anticancer Therapies","Inclusion Criteria:\n\n* At least 18 years old\n* Hispanic\u002FLatinX origin\n* Newly diagnosed cancer patients\n* Receiving anticancer treatment (may include combinations of intravenous or oral chemotherapy, targeted therapies, and\u002For immunotherapies)\n\nExclusion Criteria:\n\n* Being physically and\u002For mentally incapable of providing written consent","ALL","18 Years",{"count":101,"type":102},72,"ESTIMATED","INTERVENTIONAL",[105],"NA","This is a randomized controlled, type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a patient-reported outcomes (PRO)-driven culturally grounded supportive care navigation in reducing healthcare disparities among Hispanic\u002FLatinx patients receiving anticancer therapies. The objectives of this study are: (1) to compare the effectiveness of an ePRO-driven culturally grounded supportive care navigation versus usual care (control) in Hispanic\u002FLatinx patients undergoing anticancer treatment; and (2) to elicit perspectives from Hispanic\u002FLatinx patients, healthcare providers, and community partners on how an ePRO-driven culturally grounded supportive care navigation can address health disparities.",[108],"Cancer",[110,111,112,113],"patient navigation","patient-reported outcomes","supportive care in cancer","cancer survivorship","NOT_YET_RECRUITING","2026-08-26",{"date":117,"type":118},"2026-08-31","ACTUAL",{"date":120,"type":102},"2026-11-01",{"date":122,"type":102},"2028-12-31",{"name":5,"class":6},1]