Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-09 @ 6:40 AM
Study NCT ID:
NCT03895918
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2019-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2019-03-28', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective medication adherence', 'timeFrame': 'Up to 4 weeks post study', 'description': 'Assessed using Medication Event Monitoring Systems (MEMS) track caps.The project manager will conduct reviews of each child?s medical record to obtain data on the medication dose prescribed each day and dates when the medication was held for illness or toxicity. MEMS-based adherence variables will be constructed as a percentage based upon the ratio of the number of days with MEMS cap openings (X) to the number of days the medication was prescribed (N). Will remove days when the medication was held by the prescriber from the denominator (X/N x 100).'}], 'secondaryOutcomes': [{'measure': 'Change in parenting stress', 'timeFrame': 'Baseline up to 4 weeks post study', 'description': 'Pre and post intervention 15minute surveys'}, {'measure': 'Intervention feasibility', 'timeFrame': 'Up to 4 weeks post study', 'description': 'Assessed using survey assessments'}, {'measure': 'Change in parenting behaviors', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Pre and Post intervention 15 minute surveys'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Guardian', 'Hematologic and Lymphocytic Disorder', 'Malignant Neoplasm', 'Parent']}, 'descriptionModule': {'briefSummary': 'This trial studies how well a parenting skills intervention works in improving medication adherence in pediatric cancer patients. The parenting skills intervention provides support and skills training to parents who administer medicine daily to their child and may improve the childs taking of medications correctly as prescribed by the doctor. Ultimately, this may improve treatment outcomes, among children who are experiencing an illness.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To pilot test a novel parenting intervention. II. To examine the feasibility and preliminary efficacy of the parenting intervention on child medication adherence among children who are experiencing an illness.\n\nOUTLINE: Participants with poor medication adherence are randomized to 1 of 3 groups.\n\nEARLY GROUP: Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.\n\nDELAYED GROUP: Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.\n\nLATE GROUP: Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be a parent of a child (2 to 10 years old) with any hematology or oncology diagnosis who is receiving treatment at Roswell Park Comprehensive Cancer Center. We define parents as biological parents, adoptive parents, foster parents, stepparents, and legal guardians\n* Parent must have primary medication responsibility\n* The child's treatment must include home-based daily oral medication\n* Parent must have verbal English fluency\n* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Be a parent of a pediatric patient with any hematology or oncology diagnosis who is receiving treatment at Roswell Park and is \\< 2 or \\> 10 years old\n* Parent does not have primary medication responsibility\n* Child's treatment does not include home-based daily oral medication\n* Parent does not have verbal English fluency\n* If unable to consent or a prisoner\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study intervention"}, 'identificationModule': {'nctId': 'NCT03895918', 'briefTitle': 'Parenting Skills Intervention in Improving Medication Adherence in Pediatric Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Novel Parenting Skills Intervention to Improve Medication Adherence in Pediatric Cancer', 'orgStudyIdInfo': {'id': 'I 77618'}, 'secondaryIdInfos': [{'id': 'NCI-2019-01554', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 77618', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delayed Group (delayed parental skills)', 'description': 'Participants continue medication adherence monitoring over 2 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.', 'interventionNames': ['Other: Educational Activity', 'Procedure: Patient Monitoring', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Early Group (early parental skills)', 'description': 'Participants continue medication adherence monitoring over 1 week and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.', 'interventionNames': ['Other: Educational Activity', 'Procedure: Patient Monitoring', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Late Group (late parental skills)', 'description': 'Participants continue medication adherence monitoring over 3 weeks and then receive parental skills intervention sessions consisting of 4 integrated components: creating consistent medication routines, education in child management strategies, strategies for helping children adhere to medication, and training in specific parental behavioral techniques over 30 minutes weekly for 4 weeks.', 'interventionNames': ['Other: Educational Activity', 'Procedure: Patient Monitoring', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Educational Activity', 'type': 'OTHER', 'description': 'Undergo parenting skills intervention', 'armGroupLabels': ['Delayed Group (delayed parental skills)', 'Early Group (early parental skills)', 'Late Group (late parental skills)']}, {'name': 'Patient Monitoring', 'type': 'PROCEDURE', 'otherNames': ['monitor'], 'description': 'Undergo medication adherence monitoring', 'armGroupLabels': ['Delayed Group (delayed parental skills)', 'Early Group (early parental skills)', 'Late Group (late parental skills)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Delayed Group (delayed parental skills)', 'Early Group (early parental skills)', 'Late Group (late parental skills)']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}