The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)

NCT ID: NCT05477979

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

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.

Conditions

Lung Cancer; Psychological Stress; Immune Checkpoint Inhibitors; Cancer, Treatment-Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Exposure: psychological stress status

Intervention Type: 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.

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

Exposure: psychological stress status

Intervention Type: 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.

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.

Exposure: psychological stress status

Intervention Type: 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.

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.

Exposure: psychological stress status

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years;

2. Histologically confirmed diagnosis of NSCLC;

3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );

6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;

7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;

8. Informed and agreed to participate in the study;

Exclusion Criteria

1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;

2. Combined with other malignant tumors in the past 3 years;

3. Concurrent acute or chronic psychiatric disorders;

4. Current receiving anti-depressive or anti-anxiety therapy;

5. Previous treatment with other clinical drug trials;

6. Patients with symptomatic brain metastasis;

7. Can't cooperate with psychological scale assessment;

Cohort 2 (STRESS-LUNG-2):

1. Age ≥ 18 years；

2. Pathologically diagnosed as small cell lung cancer；

3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );

6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;

7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;

8. Informed and agreed to participate in the study;

1. Combined with other malignant tumors in the past 3 years;

2. Concurrent acute or chronic psychiatric disorders;

3. Current receiving anti-depressive or anti-anxiety therapy;

4. Previous treatment with other clinical drug trials;

5. Patients with symptomatic brain metastasis;

6. Can't cooperate with psychological scale assessment;

Cohort 3 (STRESS-LUNG-3):

1. Age ≥18 years ；

2. Pathologically diagnosed as non-small cell lung cancer;

3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;

4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；

5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );

6. Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.

6. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;

1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;

2. Combined with other malignant tumors in the past 3 years;

3. Concurrent acute or chronic psychiatric disorders;

4. Current receiving anti-depressive or anti-anxiety therapy;

5. Previous treatment with other clinical drug trials;

6. Can't cooperate with psychological scale assessment;

Cohort 4 (STRESS-LUNG-4):

1. Age ≥18 years;

2. Pathologically diagnosed as non-small-cell lung cancer；

3. Pathologically stage conformed as early stage of IA-IIIA

4. Available for tumor tissue samples；

5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );

6. Receiving radical surgery;

7. Informed and agreed to participate in the study;

1. Combined with other malignant tumors in the past 3 years;

2. Concurrent acute or chronic psychiatric disorders;

3. Current receiving anti-depressive or anti-anxiety therapy;

4. Previous treatment with other clinical drug trials;

5. Can't cooperate with psychological scale assessment;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Fang Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Wu, MD. PhD

Role: CONTACT

wufang4461@csu.edu.cn

+86 13574858332

Facility Contacts

Fang Wu, MD, PhD

Role: primary

wufang4461@csu.edu.cn

+86 13574858332

References

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.

Reference Type: DERIVED

PMID: 38740994 (View on PubMed)

Other Identifiers

XYEYY20220704

Identifier Type: -

Identifier Source: org_study_id