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NCT Number: NCT07280416

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

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.

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Key information

Conditions

Cancer Depression Anxiety Disorder Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

12 boulevard du Dr Chantemesse

Le Puy-en-Velay, 43000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: over a 12-month period

    The Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item self-report questionnaire assessing overall sleep quality and identifying sleep problems. A total score ≤5 indicates good sleep, while a score >5 reflects poor sleep quality, with high sensitivity and specificity. Using the results from all study participants, the overall prevalence of sleep disturbances will be calculated.

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

    Time frame: over a 12-month period

    Pain perception and its impact on daily functioning will be assessed using the Brief Pain Inventory (BPI). This validated questionnaire evaluates how pain affects seven aspects of a patient's life: activity, mood, walking ability, work, relationships, sleep, and enjoyment of life.

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

    Time frame: over 12-months period

    Patient anxiety and depression will be assessed using the validated Hospital Anxiety and Depression Scale (HADS). Each subscale (anxiety and depression) is scored separately: ≤7 indicates no symptoms, 8-10 suggests borderline symptoms, and ≥11 reflects definite symptoms.

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

    Time frame: over 12-months period

    The EORTC QLQ-C30 is a validated questionnaire designed to assess health-related quality of life in cancer patients, regardless of tumor site. It includes 30 items covering five functional scales (physical, role, emotional, cognitive, social), three symptom scales (fatigue, pain, nausea/vomiting), a global quality of life scale, and additional symptoms common in oncology (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Items are rated on a 4-point Likert scale, except for global quality of life, rated 1-7. It is widely used in clinical and epidemiological studies. This questionnaire will be used to assess the cancer-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie GADEA, PhD

CONTACT

[email protected]

+33 471 043 538

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Registry information

Official study title

Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.

Acronym: INDICA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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