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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer', 'timeFrame': 'over a 12-month period', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The secondary objective is to characterize the sleep quality in patients newly diagnosed with cancer.', 'timeFrame': 'over a 12-month period', 'description': '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.'}, {'measure': 'The secondary objective is to characterize cancer-related pain in patients newly diagnosed with cancer.', 'timeFrame': 'over a 12-month period', 'description': "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."}, {'measure': 'The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer.', 'timeFrame': 'over 12-months period', 'description': '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.'}, {'measure': 'The secondary objective is to characterize cancer-related quality of life in patients newly diagnosed with cancer.', 'timeFrame': 'over 12-months period', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'insomnia', 'pain', 'Depresion Anxiety disorder', 'longitudinal'], 'conditions': ['Cancer', 'Insomnia', 'Pain', 'Depression Anxiety Disorder', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of metastatic or non-metastatic cancer,\n* Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously,\n* Age ≥ 18 years,\n* Ability to read and understand French,\n* Patient covered by a social security system,\n* Signed informed consent.\n\nExclusion Criteria:\n\n* SCI questionnaire score \\<16\n* Diagnosed or controlled sleep disorders\n* 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\n* Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent"}, 'identificationModule': {'nctId': 'NCT07280416', 'acronym': 'INDICA', 'briefTitle': 'Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Emile Roux'}, 'officialTitle': 'Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.', 'orgStudyIdInfo': {'id': 'RIPH2_PANTE_INDICA_PRO'}, 'secondaryIdInfos': [{'id': 'Le Puy-en-Velay Hospital', 'type': 'OTHER', 'domain': 'Le Puy-en-Velay Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who have just been diagnosed with cancer.', 'description': 'These patients will be followed up with for one year.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emilie GADEA, PhD', 'role': 'CONTACT', 'email': 'science.writer@ch-lepuy.fr', 'phone': '+33 471 043 538'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Emile Roux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}