Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT07280416
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
Sponsor:
Centre Hospitalier Emile Roux
Organization:
Study Overview
Official Title:
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDICA
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Le Puy-en-Velay Hospital | OTHER | Le Puy-en-Velay Hospital | View |