[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":18,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":18,"enrollmentInfo":50,"targetDuration":18,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":18,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":18},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","AI-ISME\\&HE intervention group",[13],"Behavioral: AI-ISME&HE",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Usual routine care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","AI-ISME&HE","* Self-reporting treatment-related adverse events\n* Interacting with AI-ISME\\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty\n* ViviFrail-based exercise",[9],[26],{"name":27,"affiliation":28,"role":29},"I-Wen Chang, PhD","Department of Nursing, Taipei Veterans General Hospital","STUDY_CHAIR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Shiow-Ching Shun, PhD","CONTACT","+886911268998","scshun@nycu.edu.tw",{"type":37,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[39],{"name":40,"class":41},"National Yang Ming Chiao Tung University","OTHER","100649442","developing-and-testing-the-effectiveness-of-smart-healthcare-assisted-individualized-symptom-management-education-and-home-based-exercise-on-frailty-treatment-related-adverse-events-and-quality-of-life-in-advanced-gastric-cancer-patients-receiving-immunotherapy-100649442",false,"NCT07732543","Developing and Testing the Effectiveness of Smart Healthcare Assisted Individualized Symptom Management Education and Home-based Exercise on Frailty, Treatment-related Adverse Events and Quality of Life in Advanced Gastric Cancer Patients Receiving Immunotherapy","Inclusion Criteria:\n\n1. age ≥18 years\n2. diagnosed as AGC (TNM: T2\\~T4, N\\>0, Any M, Stage: III\\~IV, or unresectable GC)\n3. scheduled to receive the first cycle of immunotherapy\n4. willingness to provide written informed consent after receiving a full explanation of the study\n\nExclusion Criteria:\n\n1. a diagnosis of another type of cancer within the past five years\n2. inability to communicate clearly\n3. a diagnosis of dementia\n4. acute pulmonary embolism\n5. acute myocardial infarction\n6. extremity bone fracture within the past three months\n7. bone metastasis","ALL","18 Years",{"count":51,"type":52},110,"ESTIMATED","INTERVENTIONAL",[55],"NA","The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME\\&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and quality of life in advanced gastric cancer patients receiving immunotherapy. The main questions it aims to answer are:\n\n* Can AI-ISME\\&HE reduces frailty in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases quality of life in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases self-efficacy in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE reduces all-caused death in advanced gastric cancer patients receiving immunotherapy within two years? Researchers will compare usual routine care to see if AI-ISME\\&HE can reduce frailty, all-caused death and increase quality of life and self-efficacy.\n\nParticipants will not be blinded, but the outcome evaluator will be blinded. The participants will be asked to complete three tasks for 12 weeks:\n\n* Self-reporting treatment-related adverse events\n* Interacting with AI-ISME\\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty\n* ViviFrail-based exercise",[58,59],"Gastric Cancer (GC)","Immunotherapy","NOT_YET_RECRUITING","2026-07-23",{"date":63,"type":64},"2026-07-29","ACTUAL",{"date":66,"type":52},"2026-07-21",{"date":68,"type":52},"2030-07-31",{"name":5,"class":6}]