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

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 Overview

• Status: Recruiting
• Conditions: Sleep Disorders; Cell Lung Cancer
• Intervention / Treatment: Other: self-questionnaires exploring

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Laurent Pr CALVEL; Phone Number: +33 03 88 12 83 39; Email: laurent.calvel@chru-strasbourg.fr

Study Locations

• France
  • Grand Est
    • Strasbourg, Grand Est, France, 67117
      • Recruiting
      • HUS
      • Contact: Laurent Pr CALVEL, PU-PH; Phone Number: +33 03 88 12 83 39; Email: laurent.calvel@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of non-small cell lung cancer followed and treated by the Oncopneumology Department of the Nouvel Hôpital Civil in Strasbourg

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): April 11, 2025
• Study Completion (Estimated): June 11, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 9002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No