Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
SomOncoP
1 other identifier
observational
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 11, 2023
CompletedFirst Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedJune 12, 2026
June 1, 2026
1.3 years
February 13, 2024
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Score sleep quality criteria (Pittsburgh Sleep Quality Index)
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.
Every 14 days for 2 months
Interventions
At each stage, subjects are asked to fill in self-questionnaires exploring the quality of their sleep, their potential distressing symptoms, their psychological state and the quality of their life at that moment. They complete the self-questionnaires at t
Eligibility Criteria
Patients with a diagnosis of non-small cell lung cancer followed and treated by the Oncopneumology Department of the Nouvel Hôpital Civil in Strasbourg
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HUS
Strasbourg, Grand Est, 67117, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2024
First Posted
July 10, 2024
Study Start
December 11, 2023
Primary Completion
March 25, 2025
Study Completion
March 25, 2025
Last Updated
June 12, 2026
Record last verified: 2026-06