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

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ClinicalTrials.gov Identifier: NCT05477979
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Fang Wu, Central South University

Tracking Information
First Submitted Date July 23, 2022
First Posted Date July 28, 2022
Last Update Posted Date December 8, 2023
Actual Study Start Date June 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2023)
  • Cohort 1 & 2: Progression-free survival (PFS) [ Time Frame: 3 years ]
    Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer
  • Cohort 3: Pathologic complete response (pCR) rate [ Time Frame: 3 years ]
    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.
  • Cohort 4: Disease-free survival (DFS) [ Time Frame: 5 years ]
    The duration between the date after surgery to the date of any recurrence or death firstly
Original Primary Outcome Measures
 (submitted: July 26, 2022)
  • Objective Response Rate (ORR) [ Time Frame: 2 years ]
    The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Progression-free survival (PFS) [ Time Frame: 3 years ]
    Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced NSCLC
  • Effect of Chronic stress on efficacy of immune checkpoint inhibitors [ Time Frame: 3 years ]
    The chronic stress status including depression and anxiety symptoms were assessed by Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaire respectively. And then evaluate the impact of chronic status on the efficacy of immune checkpoint inhibitors, including ORR, PFS, and OS. PHQ-9 has 9 items, each on a scale of 0 to 3. The sum score (range 0 to 27) indicates the degree of depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderate to severe and severe levels of depression. GAD-7 has 7 items, each on a scale of 0 to 3. Higher total scores (ranging from 0 to 21) indicate higher anxious symptoms with 5 to 9 classified as mild, 10 to 14 classified as moderate, and 15 to 21 classified as moderate-severe.
Change History
Current Secondary Outcome Measures
 (submitted: December 1, 2023)
  • Overall survival (OS) [ Time Frame: 5 years ]
    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.
  • Quality of life [ Time Frame: 5 years ]
    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.
  • Objective Response Rate (ORR) [ Time Frame: 2 years ]
    The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Original Secondary Outcome Measures
 (submitted: July 26, 2022)
  • Overall survival (OS) [ Time Frame: 5 years ]
    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.
  • Effect of chronic stress on quality of life [ Time Frame: 5 years ]
    Chronic stress status including depression and anxiety symptoms. 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.
Current Other Pre-specified Outcome Measures
 (submitted: December 1, 2023)
  • The correlation between gut microbiota and chronic stress and the efficacy of ICIs [ Time Frame: 5 years ]
    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.
  • The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs [ Time Frame: 5 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.
  • The correlation between peripheral stress biomarker and immune cells signature and chronic stress and the efficacy of ICIs [ Time Frame: 5 years ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: July 26, 2022)
  • The correlation between gut microbiota and chronic stress and the efficacy of ICIs [ Time Frame: 5 years ]
    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.
  • The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs [ Time Frame: 5 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.
  • The correlation between peripheral immune cells signature and chronic stress and the efficacy of ICIs [ Time Frame: 5 years ]
    The baseline peripheral venous blood is collected and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between peripheral immune cells signature signature and chronic stress and the efficacy of ICIs during the enrolled observation process.
 
Descriptive Information
Brief Title The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)
Official Title 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)
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition
  • Lung Cancer
  • Psychological Stress
  • Immune Checkpoint Inhibitors
  • Cancer, Treatment-Related
Intervention Other: 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Exposure: psychological stress status
  • 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
    Intervention: Other: Exposure: psychological stress status
  • 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.
    Intervention: Other: Exposure: psychological stress status
  • 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.
    Intervention: Other: Exposure: psychological stress status
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 1, 2023)		 750
Original Estimated Enrollment
 (submitted: July 26, 2022)		 300
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Cohort 1 (STRESS-LUNG-1):

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;

Exclusion Criteria:

  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;

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. 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;

Exclusion Criteria:

  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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fang Wu, MD. PhD +86 13574858332 wufang4461@csu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05477979
Other Study ID Numbers XYEYY20220704
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Fang Wu, Central South University
Original Responsible Party Fang Wu, Central South University, Associate Professor
Current Study Sponsor Second Xiangya Hospital of Central South University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Second Xiangya Hospital of Central South University
Verification Date December 2023