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NCT Number: NCT06964503

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

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.

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Key information

Conditions

Cancer of Lung Anxiety Disorder/Anxiety State Anxiety Disorders Depression Disorders Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Exposure: psychological stress status

Other

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 outcomes

  1. Advanced Stage Cohort: 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

  2. Early-Stage Surgical Cohort: Disease-free survival (DFS)

    Time frame: 5 years

    The duration between the date after surgery to the date of any recurrence or death firstly

  3. neoadjuvant therapy Cohort: 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.

Secondary outcomes

  1. 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.

  2. Objective Response Rate (ORR)

    Time frame: 3 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)

Other outcomes

  1. The correlation between gut microbiota and chronic stress

    Time frame: 5 years

    The baseline faeces is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress during the enrolled observation process

  2. The correlation between peripheral stress biomarker and immune cells signature and chronic stress

    Time frame: 5 years

    The baseline peripheral venous blood is collected. The stress biomarkers including epinephrine, cytokines, 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.

  3. The correlation between tumor microenvironment signature and chronic stress

    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 during the enrolled observation process.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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