Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-06 @ 1:59 PM
Study NCT ID:
NCT06446661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for AYA patients', 'timeFrame': '1 year', 'description': 'ANC and platelet measurements are collected throughout maintenance to monitor for therapeutic goals and the potential need for dose changes as part of AYA Oncology pharmacist-led management program'}, {'measure': 'To compare clinical outcomes during and after maintenance therapy for AYA patients', 'timeFrame': '1 year', 'description': 'Any changes in chemotherapy regimen or evidence of relapsed disease including new minimal residual disease (MRD) positivity within the first year of maintenance will be recorded.'}], 'primaryOutcomes': [{'measure': 'To compare adherence to oral chemotherapy with mercaptopurine and methotrexate', 'timeFrame': '84 days', 'description': 'To compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for AYA patients with ALL on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard of care.'}], 'secondaryOutcomes': [{'measure': 'To describe the relationship between oral chemotherapy adherence and AYA patient factors', 'timeFrame': '1 year', 'description': 'At the start of cycle 1, Health Competence Beliefs Inventory (HCBI) scores will be collected as a baseline measurement of self-efficacy as measured in a prior AYA adherence study. Higher HCBI scores and lower ADI and SVM scores will be associated with higher adherence given prior associations with self-efficacy and family finances.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Chemotherapy'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Young Adults (AYA) with Acute Lymphoblastic leukemia (ALL).', 'detailedDescription': 'This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult patients with Acute Lymphoblastic Leukemia on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 15-39 years-old at the time of initial ALL diagnosis\n* Diagnosed with ALL\n* Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance.\n\nExclusion Criteria:\n\n* Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages\n* Patient does not wish to participate'}, 'identificationModule': {'nctId': 'NCT06446661', 'briefTitle': 'Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Young Adults With Acute Lymphoblastic Leukemia Using Text Messages', 'orgStudyIdInfo': {'id': 'IRB23-1519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity', 'description': 'Receives high-intensity text messaging for 2 cycles of treatment', 'interventionNames': ['Other: High Intensity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Intensity', 'description': 'Receives no texts for 1st cycle and low-intensity texts for 2nd cycle', 'interventionNames': ['Other: No Text Messagings', 'Other: Low Intensity Text Messaging']}], 'interventions': [{'name': 'High Intensity', 'type': 'OTHER', 'description': 'Daily texts', 'armGroupLabels': ['High Intensity']}, {'name': 'No Text Messagings', 'type': 'OTHER', 'description': 'Standard Care', 'armGroupLabels': ['Low Intensity']}, {'name': 'Low Intensity Text Messaging', 'type': 'OTHER', 'description': 'Weekly Texts', 'armGroupLabels': ['Low Intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Intake', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@bsd.uchicago.edu', 'phone': '855-702-8222'}, {'name': 'Wendy Stock', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago Medicine Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Clinical Trials Intake', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@bsd.uchicago.edu', 'phone': '1-855-702-8222'}], 'overallOfficials': [{'name': 'Wendy Stock', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally.\n\nData will only be shared for analysis purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}