[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608209":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":18,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":18,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Incheon St.Mary's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LLM Intervention Group","EXPERIMENTAL","Patients receive standard chemotherapy with AI-assisted symptom management. Healthcare providers input anonymized patient symptoms into a large language model system during clinic visits. The LLM generates management recommendations that physicians review and consider for treatment decisions.",[13],"Behavioral: LLM-assisted chemotherapy side effect management",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","NO_INTERVENTION","Patients receive standard chemotherapy with conventional symptom management based on institutional protocols and physician clinical judgment.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","LLM-assisted chemotherapy side effect management","Healthcare providers collect patient symptoms during clinic visits, anonymize the information, and input it into the LLM system via temporary chat sessions. The LLM generates management recommendations which physicians review and consider when adjusting treatment plans. Healthcare providers anonymize patient information and input into LLM using temporary chat sessions. LLM recommendations serve as reference only, with physicians making all final clinical decisions.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Young-Joon Kang","CONTACT","+82322805179","yjkang.md@gmail.com",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":18,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea","RECRUITING","Incheon","21431","South Korea",{"type":39,"coordinates":40},"Point",[41,42],126.70515,37.45646,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":18,"email":30},"Young Joon Kang","82-32-280-5179",{"type":49,"investigatorFullName":27,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100608209","ai-assisted-chemotherapy-side-effect-management-100608209",false,"NCT07198581","AI-Assisted Chemotherapy Side Effect Management","A Randomized Controlled Trial of AI-Assisted Chemotherapy Side Effect Management in Solid Tumor Patients","ALLIANCE","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) diagnosed with histologically confirmed solid malignancies (breast cancer, colorectal cancer)\n* Patients scheduled to receive at least 3 months of systemic chemotherapy\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Severe psychiatric disorders\n* Cognitive impairment affecting ability to report symptoms\n* Presence of cancer-related symptoms prior to chemotherapy initiation\n* Concurrent participation in trials evaluating other symptom management interventions Inability to provide informed consent Life expectancy less than 6 months","ALL","18 Years",{"count":62,"type":63},174,"ESTIMATED","INTERVENTIONAL",[66],"NA","This two-stage adaptive randomized controlled trial evaluates the feasibility and preliminary efficacy of large language model (LLM)-assisted intervention for managing chemotherapy side effects in patients with solid tumors. Adults with histologically confirmed breast or colorectal cancer scheduled for at least 3 months of systemic chemotherapy will be randomly assigned (1:1) to receive either LLM-assisted care or standard care.\n\nThe study employs an adaptive design with initial enrollment of 60 patients (30 per arm), followed by interim analysis. Unless enrollment is stopped for safety reasons identified at interim analysis, an additional 114 patients will be enrolled for a maximum total of 174 patients (87 per arm).\n\nIn the intervention group, healthcare providers input anonymized patient symptom data into an LLM system using sessions where data is not retained, which generates evidence-based management recommendations. Physicians critically review these recommendations and use them as reference for clinical decision-making, with final treatment decisions remaining under physician discretion. The control group receives standard supportive care without LLM assistance.\n\nThe primary outcome is change in health-related quality of life measured by EORTC QLQ-C30 global health status\u002FQoL scale from baseline to end of treatment. Secondary outcomes include proportion achieving clinically meaningful improvement (≥8-point increase), treatment adherence, dose intensity, healthcare resource utilization, and physician acceptance of LLM recommendations.",[69,70],"Breast Cancer","Colorectal Cancer",[72,73,74,75,76,77],"Large Language Model","LLM","Breast cancer","Side effect","Supportive care","colorectal cancer","2026-04-17",{"date":80,"type":81},"2026-04-22","ACTUAL",{"date":83,"type":81},"2025-11-12",{"date":85,"type":63},"2026-10-31",{"name":5,"class":6},1]