Clinical trial NCT06964503: Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients
Official title: Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer of Lung
Depression Disorders
Anxiety Disorder/Anxiety State
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: This study explores how psychological stress may influence the treatment response and long-term outcomes in patients with lung cancer. While advances in surgery, chemotherapy, immunotherapy, and targeted therapies have improved survival, emotional well-being remains an often-overlooked factor. We aim to investigate whether high levels of stress, anxiety, or depression at the time of diagnosis or during treatment are linked to poorer responses to therapy or shorter survival. By identifying these associations, the study hopes to highlight the importance of psychological care as part of comprehensive cancer treatment. The findings may inform future strategies to integrate mental health support into routine care for patients with both early-stage and advanced lung cancer.


Eligibility criteria: Inclusion Criteria (Advanced Stage Cohort):

Age ≥ 18 years; Histologically confirmed diagnosis of lung cancer (including both non-small cell lung cancer \[NSCLC\] and small cell lung cancer \[SCLC\]); Unresectable, locally advanced, metastatic, or recurrent disease classified as stage IIIB-IV according to the 8th edition of the AJCC TNM staging system; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; No prior systemic treatment (e.g., chemotherapy, anti-angiogenic therapy, targeted therapy, or immunotherapy); At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); Able to provide informed consent and voluntarily agree to participate in the study.

Exclusion Criteria:

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;

Inclusion Criteria (Early-Stage Surgical Cohort) 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;

Exclusion Criteria:

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;

Inclusion Criteria (neoadjuvant therapy Cohort) Adults aged ≥18 years; Histologically confirmed diagnosis of non-small cell lung cancer \[NSCLC\]; Clinical stage IB-IIIB based on the 8th edition of the AJCC TNM staging system and deemed potentially resectable after neoadjuvant therapy; At least one measurable lesion can be evaluated according to the RECIST 1.1 standard; Planned to receive or currently receiving neoadjuvant systemic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) with curative intent; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 prior to neoadjuvant treatment; No prior systemic treatment before the initiation of neoadjuvant therapy; Able to provide informed consent and voluntarily agree to participate in the study

Exclusion Criteria:

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;

Primary outcomes:
measure: Advanced Stage Cohort: Progression-free survival (PFS)
timeFrame: 3 years
measure: Early-Stage Surgical Cohort: Disease-free survival (DFS)
timeFrame: 5 years
measure: neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Objective Response Rate (ORR)
timeFrame: 3 years
Other outcomes:
measure: The correlation between gut microbiota and chronic stress
timeFrame: 5 years
measure: The correlation between peripheral stress biomarker and immune cells signature and chronic stress
timeFrame: 5 years
measure: The correlation between tumor microenvironment signature and chronic stress
timeFrame: 5 years
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