NCT07280416 Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
| NCT ID | NCT07280416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Emile Roux |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2025-12-16 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time. A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties. The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of metastatic or non-metastatic cancer, * Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously, * Age ≥ 18 years, * Ability to read and understand French, * Patient covered by a social security system, * Signed informed consent. Exclusion Criteria: * SCI questionnaire score \<16 * Diagnosed or controlled sleep disorders * Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient * Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07280416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07280416 currently recruiting?
Yes, NCT07280416 is actively recruiting participants. Contact the research team at science.writer@ch-lepuy.fr for enrollment information.
Where is the NCT07280416 trial being conducted?
This trial is being conducted at Le Puy-en-Velay, France.
Who is sponsoring the NCT07280416 clinical trial?
NCT07280416 is sponsored by Centre Hospitalier Emile Roux. The trial plans to enroll 260 participants.
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