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.
This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 4 cohorts * Cohort 1 (STRESS-LUNG-1): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of ICIs in advanced NSCLC. * Cohort 2 (STRESS-LUNG-2): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC. * Cohort 3 (STRESS-LUNG-3): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC. * Cohort 4 (STRESS-LUNG-4): A prospective, observational cohort study to explore the association of psychological stress with cancer progression, and Prognosis in early-stage NSCLC receiving radical surgery.
Study Type
OBSERVATIONAL
Enrollment
750
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.
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGCohort 1 & 2: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer
Time frame: 3 years
Cohort 3: Pathologic complete response (pCR) rate
pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.
Time frame: 3 years
Cohort 4: Disease-free survival (DFS)
The duration between the date after surgery to the date of any recurrence or death firstly
Time frame: 5 years
Overall survival (OS)
Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame: 5 years
Quality of life
Quality of life (QoL) is assessed longitude by Short Form Health Survey 36 (SF-36) and EORTC QLQ-C30 (version.3). SF-36 includes 36 items and assesses the functional status and well-being on eight multi-item subscales. The total score on each SF-36 subscale ranges between 0 and 100. A greater score indicates better QoL. The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.
Time frame: 5 years
Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 2 years
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