Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Insomnia, Pain, Depression Anxiety Disorder. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
Overview
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.
Primary outcome measures
- The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer [Time frame: over a 12-month period]
Secondary outcome measures (4)
- The secondary objective is to characterize the sleep quality in patients newly diagnosed with cancer. [Time frame: over a 12-month period]
- The secondary objective is to characterize cancer-related pain in patients newly diagnosed with cancer. [Time frame: over a 12-month period]
- The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer. [Time frame: over 12-months period]
- The secondary objective is to characterize cancer-related quality of life in patients newly diagnosed with cancer. [Time frame: over 12-months period]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- 12 boulevard du Dr Chantemesse — Le Puy-en-Velay
Identifiers
NCT: NCT07280416 · RIPH2_PANTE_INDICA · ID-RCB