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

NCT ID: NCT07280416

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2028-11-01

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.

Conditions

Cancer; Insomnia; Pain; Depression Anxiety Disorder; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who have just been diagnosed with cancer.

These patients will be followed up with for one year.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Emile Roux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Emilie GADEA, PhD

Role: CONTACT

science.writer@ch-lepuy.fr

+33 471 043 538

Other Identifiers

Le Puy-en-Velay Hospital

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH2_PANTE_INDICA_PRO

Identifier Type: -

Identifier Source: org_study_id