Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age (SOM'AJA)

Medical professionals now take into account the specificities of the care and support of Adolescents and Young Adults (AYAs). Cancer aftermaths in patients diagnosed during the AYA period are also known: the consequences of chemotherapy and radiotherapy treatments on a growing organism, the difficulty of some follow-ups, the longevity, and the delayed occurrence of certain complications.

In the general population, sleep disorders affect 40% of adolescents. About 30% of pediatric cancer survivors experience fatigue they attribute to their cancer, even years after the end of their treatment. The sleep quality of patients treated for cancer when they were AYAs, and the eventual care of sleeping disorders, are poorly studied. The investigators suppose that the oncologic treatment during this particular life stage, when sleeping disorders are already present and multifactorial, could have long-term impacts on sleep. The investigators offer to evaluate, through a questionnaire filled out by patients treated for cancer in the AYA period, the frequency of moderate to severe insomnia.

Study Overview

• Status: Recruiting
• Conditions: Cancer Survivors
• Intervention / Treatment: Other: Survey of sleep quality and associated factors

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meryl Horwitz, Dr; Phone Number: +33 492036795; Email: horwitez.m@chu-nice.fr

Study Locations

• France
  • Nice, France
    • Recruiting
    • CHU de Nice
    • Contact: Méryl Horwitz, Dr; Phone Number: +33 492036795; Email: horwitz.m@chu-nice.fr
    • Principal Investigator: Méryl Horwitz, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient treated for a cancer
• Patient aged between 15 and 24 years old at the time of the diagnosis
• Patients whom intensive treatment ended at least 3 months ago
• Patient followed in a PACAAURA cancerology center
• Life expectancy ≥ 6 months
• Karnosky index > 60%
• Patient who agrees to participate in the program and benefits from social security
• Patient able to understand, speak and read French.
• No major cognitive impairment (assessed by the patient's referees)
• No sensory disability

Exclusion Criteria:

• Patient unable to use informatic tools
• Known superior cognitive function disorders
• Progressive psychiatric pathology
• Drug user or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation of sleep quality	Other: Survey of sleep quality and associated factors; Sleep quality and associated factors (anxiety, depression, and pain) will be evaluated through an online survey on the Reseau Morphee platform, through an self-administered evaluation of the patients' pain and sleep difficulties, and a precarity scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients presenting moderate or severe insomnia	Online self-administered questionnaire filled-out by the patient (120 questions) Scores between 1 and 10, yes or no, multiple choice questions, open-ended questions	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of sleep disorders risk factors	Self-administered questionnaire filled-out by the patient (120 questions) self-administered evaluation of the patients' pain and sleep difficulties Precarity scale Scores between 1 and 10, yes or no, multiple choice questions, open-ended questions	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 5, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-PP-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No