Cancer SurvivorsSOM'AJANCT06904495
Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age
A study testing Survey of sleep quality and associated factors in people with Cancer Survivors, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Survey of sleep quality and associated factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%
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- 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
Who cannot join
- Patient unable to use informatic tools
- Known superior cognitive function disorders
- Progressive psychiatric pathology
- Drug user or alcohol abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice
Méryl Horwitz, Dr, 492036795 ext. +33, horwitz.m@chu-nice.fr
Méryl Horwitz, Dr
About this study
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.
- Conditions
- Cancer Survivors
- Being tested
- Survey of sleep quality and associated factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of sleep quality and associated factorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of sleep quality | Experimental | Not described Receives: Other: Survey of sleep quality and associated factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (1)
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Apr 2025
- Primary completion5 May 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904495
- Sponsor's protocol ID
- 25-PP-02
- Acronym
- SOM'AJA
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Quality in Patients Treated for Cancer Between 15 and 24 Years of Age
- ClinicalTrials.gov ID
- NCT06904495
- Acronym / sponsor ID
- SOM'AJA / 25-PP-02
- Conditions
- Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of sleep quality | Experimental | Other: Survey of sleep quality and associated factors |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- Patient unable to use informatic tools
- Known superior cognitive function disorders
- Progressive psychiatric pathology
- Drug user or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey of sleep quality and associated factorsSleep 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. | Other | Evaluation of sleep quality |
Primary outcome
Number of patients presenting moderate or severe insomnia
Time frame: Day 1
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
1 secondary outcome
Identification of sleep disorders risk factors
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey of sleep quality and associated factors in people with Cancer Survivors, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryl Horwitz, Dr (492036795 ext. +33, horwitez.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients presenting moderate or severe insomnia (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.