Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07280416

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

Led by Centre Hospitalier Emile Roux · Updated on 2026-02-11

260

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of metastatic or non-metastatic cancer
  • Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously
  • Age 18 years or older
  • Ability to read and understand French
  • Patient covered by a social security system
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • SCI questionnaire score less than 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

12 boulevard du Dr Chantemesse

Le Puy-en-Velay, France, 43000

Actively Recruiting

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Research Team

E

Emilie GADEA, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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