Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 7:12 AM
Study NCT ID:
NCT06074666
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2023-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the CareMeds 3 sessions', 'timeFrame': 'up to 3 years', 'description': 'enrollment rates will be measured by number of consents . Reasons for refusal will also be captured'}], 'secondaryOutcomes': [{'measure': 'Behavioral Parenting skills', 'timeFrame': 'Weeks 1, 4 and 12.', 'description': 'Self reported measure to assess the frequency of parental engagement on a scale from 1 (not at all) to 7 (Most of the time)'}, {'measure': 'Oral Chemotherapy adherence', 'timeFrame': 'UP to week 12', 'description': 'Will be measured by the number of days with MEMS cap openings to the number of days 6-MP was prescribed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia, Pediatric']}, 'descriptionModule': {'briefSummary': 'The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.', 'detailedDescription': 'This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.\n* Parent has primary medication responsibility.\n* Pediatric patient aged 3-9 years\n* Child on therapy that includes home-based oral anti-cancer medication taken at home, such as 6-MP.\n* Parent has verbal English or Spanish fluency.\n* Participant 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* Parent of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.\n* Parent does not have primary medication responsibility.\n* Pediatric patient aged 3-9 years\n* Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP).\n* Parent does not have verbal English or Spanish fluency.\n* Parent is unwilling or unable to follow protocol requirements'}, 'identificationModule': {'nctId': 'NCT06074666', 'briefTitle': 'Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3', 'orgStudyIdInfo': {'id': 'I 3774823'}, 'secondaryIdInfos': [{'id': 'R01CA258337', 'link': 'https://reporter.nih.gov/quickSearch/R01CA258337', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CareMeds Intervention', 'description': 'Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.', 'interventionNames': ['Behavioral: CareMeds Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.', 'interventionNames': ['Behavioral: Usual Care Group']}], 'interventions': [{'name': 'CareMeds Intervention', 'type': 'BEHAVIORAL', 'description': '3 parenting sessions will be offered during weeks 2 through 4 of the study period.', 'armGroupLabels': ['CareMeds Intervention']}, {'name': 'Usual Care Group', 'type': 'BEHAVIORAL', 'description': '3 parenting sessions will be offered during weeks 13 through 15 of the study period.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Bouchard, MD', 'role': 'CONTACT', 'email': 'elizabeth.Bouchard@roswellpark.org', 'phone': '716-845-8357'}], 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Elizabeth Bouchard, PhD', 'role': 'CONTACT', 'email': 'Elizabeth.Bouchard@roswellpark.rog', 'phone': '716-845-1300', 'phoneExt': '8357'}], 'overallOfficials': [{'name': 'Elizabeth Bouchard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}