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Not yet recruiting NCT06964503

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

Observational Cancer of Lung Depression Disorders Anxiety Disorder/Anxiety State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposure: psychological stress status.
Who it may be relevant to
Registry conditions: Cancer of Lung, Depression Disorders, Anxiety Disorder/Anxiety State. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Advanced Stage Cohort: Progression-free survival (PFS) [Time frame: 3 years]
  • Early-Stage Surgical Cohort: Disease-free survival (DFS) [Time frame: 5 years]
  • neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate [Time frame: 3 years]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 5 years]
  • Objective Response Rate (ORR) [Time frame: 3 years]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06964503 · LUNG-MOOD-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗