[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475980":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":10,"id":60,"slug":10,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: advanced NSCLC patients receiving first-line ICIs (STRESS-LUNG-1 study)",null,"For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy.",[13],"Other: Exposure: psychological stress status",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: limited-stage and extensive-stage SCLC patients receiving ICIs (STRESS-LUNG-2 study)","For limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: NSCLC patients receive neoadjuvant therapy of ICIs（STRESS-LUNG-3 study）","For stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4: NSCLC patients receive radical resection (STRESS-LUNG-4 study))","For early-stage patients with non-small cell lung cancer who have received radical resection.",[13],[27],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Exposure: psychological stress status","The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 were categorized as the stressed group.",[9,15,19,23],[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Fang Wu, MD. PhD","CONTACT","+86 13574858332","wufang4461@csu.edu.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Department of Oncology, The Second Xiangya Hospital, Central South University","RECRUITING","Changsha","Hunan","410011","China","CN",{"type":47,"coordinates":48},"Point",[49,50],112.97087,28.19874,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":35,"phoneExt":10,"email":36},"Fang Wu, MD, PhD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":59,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Fang Wu","Professor","Central South University","100475980",false,"NCT05477979","The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)","Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)","Cohort 1 (STRESS-LUNG-1):\n\nInclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Patients with symptomatic brain metastasis;\n7. Can't cooperate with psychological scale assessment;\n\nCohort 2 (STRESS-LUNG-2):\n\n1. Age ≥ 18 years；\n2. Pathologically diagnosed as small cell lung cancer；\n3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Patients with symptomatic brain metastasis;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 3 (STRESS-LUNG-3):\n\n1. Age ≥18 years ；\n2. Pathologically diagnosed as non-small cell lung cancer;\n3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;\n4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving PD-1\u002FPD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.\n\n6\\. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 4 (STRESS-LUNG-4):\n\n1. Age ≥18 years;\n2. Pathologically diagnosed as non-small-cell lung cancer；\n3. Pathologically stage conformed as early stage of IA-IIIA\n4. Available for tumor tissue samples；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving radical surgery;\n7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Can't cooperate with psychological scale assessment;","ALL","18 Years",{"count":69,"type":70},750,"ESTIMATED","5 Years","OBSERVATIONAL","This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.",[75,76,77,78],"Lung Cancer","Psychological Stress","Immune Checkpoint Inhibitors","Cancer, Treatment-Related",[80,81,82,83,84,85],"Lung cancer","Immune checkpoint inhibitors","Psychological stress","Cancer progression","Prognosis","Biomarker","2025-02-21",{"date":88,"type":89},"2025-02-25","ACTUAL",{"date":91,"type":89},"2020-06-01",{"date":93,"type":70},"2028-12-31",{"name":5,"class":6},1]