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

University Hospital, Strasbourg, France1 site in 1 country100 target enrollmentDecember 11, 2023

ConditionsCell Lung Cancer Sleep Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cell Lung Cancer
Sponsor: University Hospital, Strasbourg, France
Enrollment: 100
Locations: 1
Primary Endpoint: Score sleep quality criteria (Pittsburgh Sleep Quality Index)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 11, 2023

End Date

June 11, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Score sleep quality criteria (Pittsburgh Sleep Quality Index)

Time Frame: 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.