NCT06495346CompletedNot Applicable
Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
University Hospital, Strasbourg, France2 sites in 1 country37 target enrollmentStarted: December 11, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Score sleep quality criteria (Pittsburgh Sleep Quality Index)
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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