How insomnia develops during the first year after a new cancer diagnosis
Official title: Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
Run by Centre Hospitalier Emile Roux · NCT07280416 · Data updated 2026-11-12
This project will track how insomnia appears and changes during the first year after a cancer diagnosis in adults who had no prior sleep problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Centre Hospitalier Emile Roux Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Le Puy-en-Velay) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07280416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) newly diagnosed with metastatic or non-metastatic cancer who had no prior sleep problems, can read French, are covered by social security, can consent, and are receiving intravenous or subcutaneous chemotherapy or immunotherapy.
✕Probably not a fit
Patients with preexisting or treated sleep disorders, severe cognitive or major psychiatric disorders, those unable to consent, or non–French speakers are unlikely to benefit from this study's findings or be eligible to participate.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will follow adults newly diagnosed with cancer over the first year after diagnosis, with regular follow-up visits to monitor sleep and related symptoms. Participants must have had no sleep problems at diagnosis and will be receiving intravenous chemotherapy or immunotherapy. The study will record timing and persistence of insomnia and collect information on cancer treatments, other symptoms (pain, mood), and any medical or non-medical sleep treatments used. Investigators will also document referrals to psychologists for insomnia-specific therapies and measure patients' adherence to those treatments.
Why it matters
Potential benefit: If successful, the findings could help clinicians spot early insomnia in cancer patients and get them referred to effective sleep treatments sooner, improving sleep and quality of life.
How similar studies have gone: Previous longitudinal studies have documented sleep problems in cancer patients, but few focus specifically on people without prior insomnia during the first year after diagnosis, so this approach is partially novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
12 boulevard du Dr Chantemesse
Le Puy-en-Velay, France Recruiting
Study contacts
- Study coordinator: Emilie GADEA, PhD
- Email: science.writer@ch-lepuy.fr
- Phone: +33 471 043 538
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.