Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-05 @ 6:12 PM
Study NCT ID:
NCT06472804
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insomnia in Patients With Metastatic Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of clinically significant insomnia', 'timeFrame': 'Baseline', 'description': 'Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Lung Non-Small Cell Carcinoma', 'Stage IV Lung Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.\n\nOUTLINE: This is an observational study.\n\nPatients undergo medical chart review and complete a questionnaire on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic non small cell lung cancer recruited from Mayo Clinic Oncology Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of metastatic non small cell lung cancer\n\n * Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy\n * Older than 18 years old at the time of diagnosis\n\nExclusion Criteria:\n\n* Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review'}, 'identificationModule': {'nctId': 'NCT06472804', 'briefTitle': 'Insomnia in Patients With Metastatic Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Insomnia in Patients With Metastatic Non Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '19-001466'}, 'secondaryIdInfos': [{'id': 'NCI-2024-04893', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19-001466', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo medical chart review and complete a questionnaire on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Konstantinos Leventakos, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Konstantinos Leventakos, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}