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

NCT06964503 | Not Yet Recruiting

• 1 other identifier: LUNG-MOOD-001
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer of Lung; Depression Disorders; Anxiety Disorder/Anxiety State

Outcome Measures

Primary Outcomes (3)

• Advanced Stage Cohort: Progression-free survival (PFS)

  Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer

  3 years

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

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

  5 years

• neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate

  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.

  3 years

Secondary Outcomes (2)

• Overall survival (OS)

  5 years

• Objective Response Rate (ORR)

  3 years

Other Outcomes (3)

• The correlation between gut microbiota and chronic stress

  5 years

• The correlation between peripheral stress biomarker and immune cells signature and chronic stress

  5 years

• The correlation between tumor microenvironment signature and chronic stress

  5 years

Study Arms (3)

Advanced Stage Cohort

Other: Exposure: psychological stress status

Early-Stage Surgical Cohort

Other: Exposure: psychological stress status

neoadjuvant therapy Cohort

Other: Exposure: psychological stress status

Interventions

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.

Advanced Stage Cohort; Early-Stage Surgical Cohort; neoadjuvant therapy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Lung Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2031
• Last Updated: May 9, 2025

Record last verified: 2025-05