Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 8:00 AM
Study NCT ID:
NCT05150028
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rates', 'timeFrame': 'Up to 8 weeks', 'description': 'Feasibility of intervention as assessed by retention rates'}], 'secondaryOutcomes': [{'measure': 'Feasibility of universal SDOA screening', 'timeFrame': 'up to 8 weeks', 'description': 'Will be assessed by results of SDOA questionnaire an 8 item questionnaire rated on a 5-point Likert scale (0-I never experienced this ; 5 - I experience this quite a lot)'}, {'measure': 'Provider satisfaction with barrier reports', 'timeFrame': 'up to 8 weeks', 'description': 'REDCap analytics will track the rate of opened barrier reports'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medication Adherence']}, 'descriptionModule': {'briefSummary': 'To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors', 'detailedDescription': 'To conduct a pilot study to assess the feasibility and acceptability of the Social Determinants of Adherence intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParents/caregivers of pediatric patients must meet the following criteria to be eligible:\n\n* Parents/guardians of child that has been diagnosed with any cancer.\n* Parents/guardians of child with any cancer between age 0 and 18.\n* Parents/guardians of child on home-based oral anti-cancer therapy or supportive care therapy.\n* The clinician for the family agrees to participate in the study.\n\nExclusion Criteria:\n\n* Participants will be excluded from this study if unwilling or unable to complete the assessment in English'}, 'identificationModule': {'nctId': 'NCT05150028', 'briefTitle': 'A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport', 'orgStudyIdInfo': {'id': 'I 2048021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - Pediatric parent/caregiver', 'description': 'Questionnaires along with educational videos', 'interventionNames': ['Behavioral: Patient participation']}, {'type': 'EXPERIMENTAL', 'label': 'Clinicians', 'description': 'Will complete pre and post survey about medication education practices', 'interventionNames': ['Other: Clinician barrier reports']}], 'interventions': [{'name': 'Patient participation', 'type': 'BEHAVIORAL', 'description': 'Questionnaire', 'armGroupLabels': ['Intervention - Pediatric parent/caregiver']}, {'name': 'Clinician barrier reports', 'type': 'OTHER', 'description': 'How many times a 7 question Survey on medication education practices is opened', 'armGroupLabels': ['Clinicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Elizabeth Bouchard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}