Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer

Recruiting

• Conditions: Sleep Disorders; Cell Lung Cancer

• Registration Number: NCT06495346
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.

This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-11
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-04-11
• Study Completion: 2025-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient aged 18 and over.
• Being monitored and treated for non-small cell lung cancer.
• With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
• With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG <2).
• Able to understand the study documents written in French
• Able to complete the study questionnaires written in French.
• Contactable by telephone throughout the study
• Affiliated to a social security scheme or entitled beneficiary
• Not opposed to taking part in the study

Exclusion Criteria

• Patient refusing to take part in the study
• With a mental illness of the psychosis type monitored and treated prior to the study
• Patient under guardianship or curatorship
• Patient under court protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score sleep quality criteria (Pittsburgh Sleep Quality Index)	Every 14 days for 2 months	The overall score ranging from 0 to 21 points. A score of 0 means that there is no difficulty sleeping, and 21 indicates, on the contrary, major difficulties.

Trial Locations

Locations (1)

HUS; 🇫🇷 Strasbourg, Grand Est, France