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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: advanced NSCLC patients receiving first-line ICIs (STRESS-LUNG-1 study) | For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy. |
| |
| 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 |
| |
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: psychological stress status | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 & 2: Progression-free survival (PFS) | Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer | 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. | 3 years |
| Cohort 4: Disease-free survival (DFS) | The duration between the date after surgery to the date of any recurrence or death firstly | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between gut microbiota and chronic stress and the efficacy of ICIs | The baseline fetal is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress and the efficacy of ICIs during the enrolled observation process. | 5 years |
| The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs |
Cohort 1 (STRESS-LUNG-1):
Inclusion Criteria:
Exclusion Criteria:
Cohort 2 (STRESS-LUNG-2):
Exclusion Criteria:
Cohort 3 (STRESS-LUNG-3):
6. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;
Exclusion Criteria:
Cohort 4 (STRESS-LUNG-4):
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wu, MD. PhD | Contact | +86 13574858332 | wufang4461@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, The Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38740994 | Derived | Zeng Y, Hu CH, Li YZ, Zhou JS, Wang SX, Liu MD, Qiu ZH, Deng C, Ma F, Xia CF, Liang F, Peng YR, Liang AX, Shi SH, Yao SJ, Liu JQ, Xiao WJ, Lin XQ, Tian XY, Zhang YZ, Tian ZY, Zou JA, Li YS, Xiao CY, Xu T, Zhang XJ, Wang XP, Liu XL, Wu F. Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer. Nat Med. 2024 Jun;30(6):1680-1688. doi: 10.1038/s41591-024-02929-4. Epub 2024 May 13. |
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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. |
| 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) | 2 years |
The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and chronic stress and the efficacy of ICIs during the enrolled observation process. |
| 5 years |
| The correlation between peripheral stress biomarker and immune cells signature and chronic stress and the efficacy of ICIs | The baseline peripheral venous blood is collected. The stress biomarkers including epinephrine, norepinephrine, cortisol and ACTH. The peripheral immune cells signature and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. | 5 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013315 | Stress, Psychological |
| D016609 | Neoplasms, Second Primary |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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