Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 6:21 AM
Study NCT ID:
NCT04712604
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the intervention', 'timeFrame': '4 weeks', 'description': 'Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.'}, {'measure': 'Acceptability of the intervention', 'timeFrame': '4 weeks', 'description': 'Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as "satisfactory" or better.'}], 'secondaryOutcomes': [{'measure': 'Change in sleep disturbance', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Change in sleep disturbance as measured by the Pittsburgh Sleep Quality Index (PSQI). PSQI has a total score ranging from 0 to 21, where lower score indicates healthier sleep quality.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Change in quality of life as measured by the Patient-reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 has a total score ranging from 20-80, with lower scores indicating better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep disturbance in GI cancer patients and their sleep partner'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '37312582', 'type': 'DERIVED', 'citation': 'Kim Y, Ting A, Tsai TC, Carver CS. Dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers: A feasibility study. Palliat Support Care. 2024 Apr;22(2):226-235. doi: 10.1017/S1478951523000627.'}, {'pmid': '36704757', 'type': 'DERIVED', 'citation': 'Kim Y, Ting A, Steel JL, Tsai TC. Protocol of a dyadic sleep intervention for adult patients with cancer and their sleep-partner caregivers. Contemp Clin Trials Commun. 2023 Jan 16;32:101064. doi: 10.1016/j.conctc.2023.101064. eCollection 2023 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients:\n\n1. newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating\n2. 18 years or older\n3. able to speak/read English at the 5th grade level\n4. having a consistent partner who is involved in daily activities including sleep\n5. having 5 or greater score on the Pittsburgh Sleep Quality Index.\n\nSleep partners:\n\n1. 18 years or older\n2. able to speak/read English at the 5th grade level\n3. a partner of the patient who is involved in the patient's daily activities including sleep\n4. having similar circadian rhythm/sleep patterns with the patient\n5. having 5 or greater score on the Pittsburgh Sleep Quality Index.\n\nExclusion Criteria:\n\nPatients and their sleep partners:\n\n1. having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated\n2. having active suicidality in the past year\n3. currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)\n4. currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower\n5. having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less\n6. unable to see or hear\n7. at the end of life (life expectancy of less than a month)\n8. unwilling to change their current sleep-related habits in near future."}, 'identificationModule': {'nctId': 'NCT04712604', 'briefTitle': 'Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program', 'orgStudyIdInfo': {'id': '20201067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSOS Group', 'description': 'The participants in this group will receive the MSOS Intervention for 4 consecutive weeks.', 'interventionNames': ['Behavioral: My Sleep Our Sleep (MSOS) Program']}], 'interventions': [{'name': 'My Sleep Our Sleep (MSOS) Program', 'type': 'BEHAVIORAL', 'description': 'MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.', 'armGroupLabels': ['MSOS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Youngmee Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Youngmee Kim', 'investigatorAffiliation': 'University of Miami'}}}}