Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT06468618
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment Rate', 'timeFrame': 'Screening (Day -30 to -1)', 'description': 'Defined as the proportion of eligible participants approached by research staff and consent to participate in the study with the cutoff set at ≥30% of eligible participants that are approached and agree to participate.'}, {'measure': 'Acceptability of Intervention Measure Scale Score', 'timeFrame': 'At Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': 'Participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention, on a 5-point scale with options ranging from Completely Agree to Completely Disagree.'}, {'measure': 'DREAMS Care Kit Usage Rate', 'timeFrame': 'At Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': 'Feasibility of the DREAMS Program intervention is defined as ≥50% of participants reporting usage of at least one of the Care Kit materials.'}, {'measure': 'Intervention Assessment Completion Rate', 'timeFrame': 'At Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': 'Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment.'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire', 'timeFrame': 'Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': "An 8-item measure used to assess the extent of a child's poor sleep. The minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes."}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire', 'timeFrame': 'Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': "An 8-item measure used to assess the extent of the consequences of a child's poor sleep. he minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes."}, {'measure': 'Sleep Diary', 'timeFrame': 'Daily, for 1 week, during the study period.', 'description': "A self-report of a participant's daily sleep patterns, including bedtime and total sleep duration."}, {'measure': 'Program Experience', 'timeFrame': 'At Follow-up Assessment Visit (Day 21, up to Day 28)', 'description': 'Open-ended questions regarding what was liked/disliked about the Care Kit materials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stem Cell Transplant Complications', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '37779507', 'type': 'BACKGROUND', 'citation': 'Fidler AL, Waitt J, Lehmann LE, Solet JM, Duffy JF, Gonzalez BD, Beebe DW, Fedele DA, Zhou ES. Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients. J Hosp Med. 2023 Nov;18(11):999-1003. doi: 10.1002/jhm.13218. Epub 2023 Oct 2.'}]}, 'descriptionModule': {'briefSummary': "Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.", 'detailedDescription': "In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.\n\nThis is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.\n\nThe research study procedures include screening for eligibility and surveys.\n\nParticipation in this research study is expected to last for about 2 weeks.\n\nIt is expected that about 10 children will take part in this research study.\n\nThe American Cancer Society is supporting this research study with grant funding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 9-17 years.\n* Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.\n* English speaking child and primary caregiver (parent/guardian).\n\nExclusion Criteria:\n\n-Primary team declines permission to approach."}, 'identificationModule': {'nctId': 'NCT06468618', 'acronym': 'DREAMS', 'briefTitle': 'Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients', 'orgStudyIdInfo': {'id': '24-254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DREAMS Program', 'description': 'Enrolled participants and parent(s) will complete:\n\n* Baseline visit with survey\n* Standard of care stem cell infusion\n* In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit.\n* Follow up survey', 'interventionNames': ['Behavioral: DREAMS Program Video and Care Kit']}], 'interventions': [{'name': 'DREAMS Program Video and Care Kit', 'type': 'BEHAVIORAL', 'description': 'A pediatric, circadian health program comprised of an introductory video to sleep experiences for stem cell transplant recipients, strategies to improve sleep, and a Sleep and Circadian Care Kit which includes ear plugs, a white noise machine, an eye mask, a lightbox, and kit instructions. Actigraph, Fitbit, and tablet will be provided to participant and family.', 'armGroupLabels': ['DREAMS Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucille Lokko, BA', 'role': 'CONTACT', 'email': 'lucille_lokko@dfci.harvard.edu', 'phone': '617-632-6221'}, {'name': 'Eric Zhou, PhD', 'role': 'CONTACT', 'phone': '617-632-6162'}], 'facility': 'Boston Children's Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucille Lokko', 'role': 'CONTACT', 'email': 'lucille_lokko@dfci.harvard.edu', 'phone': '617-632-6221'}, {'name': 'Eric Zhou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lucille Lokko, BA', 'role': 'CONTACT', 'email': 'lucille_lokko@dfci.harvard.edu', 'phone': '617-632-6221'}, {'name': 'Eric Zhou, PhD', 'role': 'CONTACT', 'phone': '617-632-6162'}], 'overallOfficials': [{'name': 'Eric Zhou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Zhou, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}