RecruitingNCT06975384

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging

Sponsor

Second Xiangya Hospital of Central South University

Enrollment

1,270 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Sleep Disturbance Cancer, Treatment-Related Immune Checkpoint Inhibitors

Summary

This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether sleep problems affect how well immunotherapy (checkpoint inhibitor drugs) works in people with advanced non-small cell lung cancer (NSCLC), and whether sleep disturbance influences overall survival. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of advanced or metastatic NSCLC (stage IIIB–IV) - You have not yet received treatment for advanced disease - You have at least one measurable tumor on imaging - You are physically well enough to participate (ECOG 0–1) - You are scheduled to receive PD-1/PD-L1 immunotherapy (alone or with chemotherapy) **You may NOT be eligible if...** - Your lung cancer has a targetable mutation (such as EGFR, ALK, or ROS1) that is better treated with targeted therapy - You have untreated brain metastases - You have serious other medical conditions affecting participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExposure: sleep disturbance status

The assessment of sleep disturbance was conducted using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Patients with a PSQI score \> 5 or an ISI score \> 7 were categorized as sleep disturbance patients. The assessment of chronotype was conducted using reduced Morningness-Eveningness Questionnaire (rMEQ). Patients with an rMEQ score 18-25 were categorized as the morning type, those with an rMEQ score 12-17 as the intermediate type, and those with an rMEQ score 4-11 as the evening type.