RecruitingNCT05477979

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)


Sponsor

Second Xiangya Hospital of Central South University

Enrollment

750 participants

Start Date

Jun 1, 2020

Study Type

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

Min Age: 18 Years

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

OTHERExposure: 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.


Locations(1)

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

Changsha, Hunan, China

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NCT05477979


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