CancerInsomniaPainDepression Anxiety DisorderQuality of Life
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer — over a 12-month period The primary objective of this longitudinal study is to diagnose insomnia and track its evolution and severity in patients newly diagnosed with cancer over the first year after diagnosis. Two validated questionnaires will be repeatedly administered: the Sleep Condition Indicator (SCI) and the Insomnia Severity Index (ISI). The SCI, based on DSM-5 criteria, identifies probable clinical insomnia by assessing symptom frequency, duration (difficulty falling asleep, night awakenings, early awakening), and functional impact. The ISI is a 7-item questionnaire evaluating perceived sleep difficulties over the past two weeks, including sleep initiation, maintenance, early awakening, daytime functioning, and distress. Total scores classify insomnia as absent, subclinical, moderate, or severe.
Trial sites (1)
Facility
City
Region
Status
12 boulevard du Dr Chantemesse
Le Puy-en-Velay
France
Recruiting
More Centre Hospitalier Emile Roux trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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