NCT06904495

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

March 21, 2025

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Identification of sleep disorders risk factors

    Day 1

Study Arms (1)

Evaluation of sleep quality

EXPERIMENTAL
Other: Survey of sleep quality and associated factors

Interventions

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.

Evaluation of sleep quality

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

Central Study Contacts

Meryl Horwitz, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 1, 2025

Study Start

April 15, 2025

Primary Completion

May 5, 2026

Study Completion

May 5, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations