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)
Second Xiangya Hospital of Central South University
750 participants
Jun 1, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Cohort 1 (STRESS-LUNG-1):
- Age ≥ 18 years;
- Histologically confirmed diagnosis of NSCLC;
- Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- Informed and agreed to participate in the study;
Exclusion Criteria49
- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Patients with symptomatic brain metastasis;
- Can't cooperate with psychological scale assessment;
- Cohort 2 (STRESS-LUNG-2):
- Age ≥ 18 years;
- Pathologically diagnosed as small cell lung cancer;
- Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- Informed and agreed to participate in the study;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Patients with symptomatic brain metastasis;
- Can't cooperate with psychological scale assessment;
- Cohort 3 (STRESS-LUNG-3):
- Age ≥18 years ;
- Pathologically diagnosed as non-small cell lung cancer;
- Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
- At least one measurable lesion can be evaluated according to the RECIST 1.1 standard;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.
- \. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;
- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Can't cooperate with psychological scale assessment;
- Cohort 4 (STRESS-LUNG-4):
- Age ≥18 years;
- Pathologically diagnosed as non-small-cell lung cancer;
- Pathologically stage conformed as early stage of IA-IIIA
- Available for tumor tissue samples;
- Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- Receiving radical surgery;
- Informed and agreed to participate in the study;
- Combined with other malignant tumors in the past 3 years;
- Concurrent acute or chronic psychiatric disorders;
- Current receiving anti-depressive or anti-anxiety therapy;
- Previous treatment with other clinical drug trials;
- Can't cooperate with psychological scale assessment;
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05477979