NCT06495346

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

February 13, 2024

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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

Locations