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

NCT07280416 | Recruiting DMC

• 2 other identifiers: RIPH2_PANTE_INDICA_PROLe Puy-en-Velay Hospital
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

cancer; insomnia; pain; Depresion Anxiety disorder; longitudinal

Outcome Measures

Primary Outcomes (1)

• The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer

  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.

  over a 12-month period

Secondary Outcomes (4)

• The secondary objective is to characterize the sleep quality in patients newly diagnosed with cancer.

  over a 12-month period

• The secondary objective is to characterize cancer-related pain in patients newly diagnosed with cancer.

  over a 12-month period

• The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer.

  over 12-months period

• The secondary objective is to characterize cancer-related quality of life in patients newly diagnosed with cancer.

  over 12-months period

Study Arms (1)

Patients who have just been diagnosed with cancer.

These patients will be followed up with for one year.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes adult patients (≥18 years) with a confirmed diagnosis of metastatic or non-metastatic cancer, who are scheduled to receive intravenous chemotherapy and/or immunotherapy (intravenous or subcutaneous). Eligible participants must be able to read and understand French, be covered by a social security system, and provide signed informed consent. Patients must not have pre-existing sleep disorders (SCI score ≥16) and must not have severe cognitive or major psychiatric disorders that could interfere with participation. Patients in emergency situations or under legal protection measures unable to consent are excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (1)

12 boulevard du Dr Chantemesse

Le Puy-en-Velay, 43000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emilie GADEA, PhD

CONTACT

+33 471 043 538; science.writer@ch-lepuy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

FR (1)