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

June 11, 2026 updated by: University Hospital, Strasbourg, France

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Grand Est
      • Strasbourg, Grand Est, France, 67117
        • HUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 14 days for 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 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)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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