Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-28 @ 7:12 PM
Study NCT ID:
NCT05582759
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility as measured by percentage of target sample enrolled', 'timeFrame': 'Through study completion (an average of 24 months)'}, {'measure': 'Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months', 'timeFrame': 'Two months'}, {'measure': 'Feasibility as measured by percent attrition for the four teleCBT-I sessions', 'timeFrame': 'Two months'}], 'secondaryOutcomes': [{'measure': "Change from baseline for participants' ReadiScores", 'timeFrame': 'one month, two months', 'description': 'ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)'}, {'measure': "Change from baseline for participants' sleep metrics for total sleep time (hours per night)", 'timeFrame': 'one month, two months', 'description': 'total sleep time in hours per night measured by the SAFTE algorithm.'}, {'measure': "Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)", 'timeFrame': 'one month, two months', 'description': 'sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.'}, {'measure': 'Change from baseline in insomnia severity', 'timeFrame': 'one months, two months', 'description': 'Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.'}, {'measure': 'Change from baseline in sleep quality', 'timeFrame': 'one months, two months', 'description': 'Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality'}, {'measure': 'Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life', 'timeFrame': 'one months, two months', 'description': 'Measured by items and total score on the Patient Reported Outcomes Management System-29+2 (PROPr). Likert style items with variable ranges, raw scores converted to T-scores and standard deviations.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Sleep Disturbance', 'Fatigue', 'Memory', 'Concentration'], 'conditions': ['Prostate Cancer', 'Sleep Disturbance', 'Fatigue', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years old\n* Diagnosed with any stage of prostate cancer\n* Receiving androgen deprivation therapy\n* Able to speak and read English\n* Score \\>/= 8 on Insomnia Severity Index\n\nExclusion Criteria:\n\n* Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent\n* Sleep apnea not utilizing/or adherent to CPAP\n* Uncontrolled restless legs syndrome"}, 'identificationModule': {'nctId': 'NCT05582759', 'acronym': 'SHERE-Relief 2', 'briefTitle': 'Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT) (SHERE-Relief 2)', 'orgStudyIdInfo': {'id': 'STUDY00148836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SH/ReadiWatchTM', 'description': 'Participants receive real-time feedback on sleep metrics and sleep hygiene education', 'interventionNames': ['Behavioral: SH/ReadiWatchTM']}, {'type': 'EXPERIMENTAL', 'label': 'teleCBT-I + SH/ReadiWatchTM', 'description': 'Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia', 'interventionNames': ['Behavioral: teleCBT-I + SH/ReadiWatchTM']}], 'interventions': [{'name': 'teleCBT-I + SH/ReadiWatchTM', 'type': 'BEHAVIORAL', 'description': 'Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention', 'armGroupLabels': ['teleCBT-I + SH/ReadiWatchTM']}, {'name': 'SH/ReadiWatchTM', 'type': 'BEHAVIORAL', 'description': 'Participants receive real time feedback on sleep metrics and education on sleep hygiene', 'armGroupLabels': ['SH/ReadiWatchTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Jamie Myers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oncology Nursing Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}