[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552121":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":24,"responsibleParty":35,"collaborators":24,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":24,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":24,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":24,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Follow-up Group","EXPERIMENTAL","Participants in this group will receive comprehensive follow-up care starting from the 4th week post-surgery. Every 3 weeks, they will undergo a thorough assessment that includes:\n\nSymptom Assessment: Comprehensive evaluation of symptoms. Nutritional Assessment: Using internationally recognized tools such as NRS 2002 and PG-SGA.\n\nPsychological Assessment: Utilizing tools such as the Distress Thermometer (DT), Generalized Anxiety Disorder 7-item scale (GAD-7), Fear of Cancer Recurrence 7-item scale (FCR-7), Insomnia Severity Index (ISI), and the Patient Health Questionnaire 9-item depression scale (PHQ-9).",[13],"Other: Enhanced Follow-up",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Follow-up Group","ACTIVE_COMPARATOR","Participants in this group will receive standard postoperative follow-up care, which includes medical examinations and treatments as necessary. Nutritional and psychological assessments will only be conducted if deemed necessary by the patient or the healthcare provider. This group will serve as the control group for comparison with the enhanced follow-up group.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Enhanced Follow-up","Participants will receive comprehensive follow-up care starting from the 4th week post-surgery. Every 3 weeks, they will undergo a thorough assessment that includes:\n\nSymptom Assessment Nutritional Assessment (using NRS 2002 and PG-SGA) Psychological Assessment (using DT, GAD-7, FCR-7, ISI, PHQ-9)",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Dazhi Xu, MD, PHD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Bo Sun, MD, PHD","CONTACT","18521064063","15111220073@fudan.edu.cn",{"type":28,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dazhi Xu","Professor","100552121","enhanced-vs-routine-follow-up-after-total-gastrectomy-for-advanced-gastric-cancer-a-randomized-controlled-trial-100552121",false,"NCT06468969","Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial","A Prospective, Single-Center, Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer","Inclusion Criteria:\n\n* Age: 18 to 72 years at the time of informed consent.\n* Underwent radical total gastrectomy.\n* Postoperative pathology confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction.\n* Estimated survival time ≥3 months.\n* Good cognitive and reading abilities, capable of completing questionnaires.\n* Willing and able to provide written informed consent for the study.\n\nExclusion Criteria:\n\n* Participation in another clinical trial within 4 weeks prior to enrollment.\n* Patients with other malignancies.\n* Clinically significant cardiovascular disease, such as heart failure (NYHA III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, or hypertension.\n* Neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis.\n* Active infectious diseases, such as active hepatitis or tuberculosis.\n* Uncontrolled systemic diseases, such as poorly controlled diabetes.\n* Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray\u002FCT.\n* Pregnant or breastfeeding.","ALL","18 Years","72 Years",{"count":49,"type":50},158,"ESTIMATED","INTERVENTIONAL",[53],"NA","The goal of this clinical trial is to compare the effectiveness of enhanced follow-up with standard follow-up in postoperative patients with advanced gastric cancer who have undergone radical gastrectomy. The main questions it aims to answer are:\n\nCan enhanced follow-up alleviate symptom burden and improve quality of life? What is the impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery?\n\nParticipants will:\n\nBe randomly assigned to either the enhanced follow-up group or the standard follow-up group.\n\nUndergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks (enhanced follow-up group).\n\nReceive routine postoperative follow-up including medical examinations and treatments as needed, with additional assessments only when necessary (standard follow-up group).\n\nResearchers will compare the enhanced follow-up group with the standard follow-up group to see if enhanced follow-up can improve quality of life and increase overall survival rates at 3 and 5 years post-surgery.\n\nOutcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and overall survival rates. This prospective, single-center, randomized controlled clinical trial will span 5 years from the approval by the institutional ethics committee and will include 158 patients.",[56,57,58,59,60],"Gastric Cancer","Total Gastrectomy","Postoperative Care","Quality of Life","Follow-up","NOT_YET_RECRUITING","2024-06-16",{"date":64,"type":65},"2024-06-21","ACTUAL",{"date":67,"type":50},"2024-07-01",{"date":69,"type":50},"2029-07-01",{"name":5,"class":6}]