Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Advanced Stage Cohort: Progression-free survival (PFS) [Срок оценки: 3 years]
• Early-Stage Surgical Cohort: Disease-free survival (DFS) [Срок оценки: 5 years]
• neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Overall survival (OS) [Срок оценки: 5 years]
• Objective Response Rate (ORR) [Срок оценки: 3 years]

Критерии участия

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.

Критерии исключения

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;

Критерии исключения

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

Критерии исключения

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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06964503 · LUNG-MOOD-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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