RecruitingNCT07280416

Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer

Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.


Sponsor

Centre Hospitalier Emile Roux

Enrollment

260 participants

Start Date

Dec 16, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This French observational study is tracking how sleep problems (insomnia) develop and change over the first year after a new cancer diagnosis, in patients receiving intravenous chemotherapy or immunotherapy. **You may be eligible if...** - You have been newly diagnosed with any type of cancer (metastatic or non-metastatic) - You are receiving intravenous chemotherapy and/or immunotherapy - You are 18 or older - You can read and understand French - You are covered by a social security system **You may NOT be eligible if...** - You score below 16 on the SCI (a sleep questionnaire, indicating no significant insomnia) - You already have a diagnosed or treated sleep disorder - You have severe cognitive impairment (e.g., Alzheimer's disease) or major psychiatric disorders - You are in an emergency situation or under legal protection (guardianship) and cannot consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

12 boulevard du Dr Chantemesse

Le Puy-en-Velay, France

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NCT07280416


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