Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 12:39 AM
Study NCT ID:
NCT05108233
Status:
WITHDRAWN
Last Update Posted:
2025-09-29
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI agreed to close study as prompted by PRMC inquiry', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in bed', 'timeFrame': 'Up to study completion; approximately 12 months', 'description': 'The time difference between time to get into bed and time to get up, measured in minutes'}, {'measure': 'Sleep latency', 'timeFrame': 'Up to study completion; approximately 12 months', 'description': 'How long it takes to sleep, measured in minutes.'}, {'measure': 'Number of nighttime awakening', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Sleep maintenance latency', 'timeFrame': 'Up to study completion; approximately 12 months', 'description': 'How long it takes to fall back to sleep, measured in minutes.'}, {'measure': 'Per-patient average score on Richards-Campbell Sleep Questionnaire', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Sleep hygiene', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Barriers to sleep quality', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Per-patient sum of scores on Epworth Sleepiness Scale', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Per-patient sum of positive responses on STOP-BANG', 'timeFrame': 'Up to study completion; approximately 12 months'}, {'measure': 'Per-patient sum of scores on Patient Health Questionnaire-2', 'timeFrame': 'Up to study completion; approximately 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Head and Neck Neoplasm']}, 'descriptionModule': {'briefSummary': 'This study examines how head and neck cancer treatment affects quality of sleep over time and factors that contribute to sleep quality. Sleep plays a critical role in healing and quality of life, and recent studies investigating sleep disorders in head and neck cancer patients reveal sleep quality is a major determinant of post-treatment outcomes. Information from this study may help researchers better understand how treatment impacts sleep quality so that they can make changes that may help improve patient sleep quality.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.\n\nII. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 \\[PHQ-2\\]), under different stages of post-op treatment and different environment.\n\nII. To evaluate the association between Fitbit actigraphy data (i.e. the 5th component of sleep quality) and the first 4 components of sleep quality for inpatients.\n\nIII. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.\n\nEXPLORATORY OBJECTIVE:\n\nI. To assess whether survey results warrant additional counseling or patient education.\n\nOUTLINE:\n\nCOHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week).\n\nCOHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months).\n\nCOHORT 2: Patients complete surveys over 15 minutes once.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with head and neck cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Adult at least 18 years old\n* Capable of giving informed consent\n* Diagnosed with head and neck cancer (previously untreated, any stage)\n* Treatment plan involves surgery\n* Willing to comply with all study procedures and be available for the duration of the study\n* English-speaking\n\nExclusion Criteria:\n\n* Non-English speaking\n* Pre-existing sleep disorder defined below:\n\n * Obstructive sleep apnea\n * Insomnia\n * Narcolepsy\n * Restless leg syndrome\n * Rapid eye movement (REM) sleep behavior disorder'}, 'identificationModule': {'nctId': 'NCT05108233', 'briefTitle': 'Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course', 'orgStudyIdInfo': {'id': '21D.668'}, 'secondaryIdInfos': [{'id': 'JT 16663', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey)', 'description': 'COHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week).\n\nCOHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months).\n\nCOHORT 2: Patients complete surveys over 15 minutes once.', 'interventionNames': ['Other: Survey Administration']}], 'interventions': [{'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete survey', 'armGroupLabels': ['Observational (survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}