Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT05595135
Status:
WITHDRAWN
Last Update Posted:
2025-04-29
First Post:
2022-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'staffing', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-time oral anticancer medication (OAM) medication adherence', 'timeFrame': 'At baseline', 'description': 'Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals.'}, {'measure': 'Real-time oral anticancer medication (OAM) medication adherence', 'timeFrame': 'at 1 month', 'description': 'Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals.'}, {'measure': 'Real-time oral anticancer medication (OAM) medication adherence', 'timeFrame': 'At 2 months', 'description': 'Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals.'}, {'measure': 'MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response', 'timeFrame': 'At baseline', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}, {'measure': 'MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response', 'timeFrame': 'At 1 month', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}, {'measure': 'MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response', 'timeFrame': 'At 2 months', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}], 'secondaryOutcomes': [{'measure': 'Complete remission (CR)', 'timeFrame': 'At baseline, 1, and 2 months', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence'}, {'measure': 'Incomplete blood count recovery (Cri)', 'timeFrame': 'At baseline, 1, and 2 months', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}, {'measure': 'Partial remissions (PR)', 'timeFrame': 'At baseline, 1, and 2 months', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}, {'measure': 'Morphologic leukemia-free state (MLFS)', 'timeFrame': 'At baseline, 1, and 2 months', 'description': 'Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (AML). Medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a barrier to effective treatment. Collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to AML patients who are taking oral anti-cancer medications.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.\n\nSECONDARY OBJECTIVE:\n\nI. To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.\n\nEXPLORATORY OBJECTIVE:\n\nI. To summarize and assess other patient-reported outcomes, collected either as patient chart review or through self-reported survey, as well as the patient post-intervention interviews.\n\nOUTLINE:\n\nPatients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute myeloid leukemia (AML)\n* Patients will be or is taking venetoclax (or any other oral anticancer medication) as part of their first line therapy\n* Has a phone with text capabilities\n* Among patients aged 18 and older we will enroll participants regardless of race or ethnicity\n\nExclusion Criteria:\n\n* Individuals who are terminally ill (defined as having less than 2 months to live)\n* Individuals for whom there is documentation of inability to provide consent in the medical record\n* Do not speak/read English\n* This study will exclude pediatric patients (defined as individuals under age 18 years)'}, 'identificationModule': {'nctId': 'NCT05595135', 'briefTitle': 'Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients', 'orgStudyIdInfo': {'id': '22D.340'}, 'secondaryIdInfos': [{'id': 'JT 19501', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health services research (text messages, smart pill bottle)', 'description': 'Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.', 'interventionNames': ['Other: Text Message-Based Navigation Intervention', 'Other: Behavioral, Psychological or Informational Intervention', 'Other: Survey Administration', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Text Message-Based Navigation Intervention', 'type': 'OTHER', 'otherNames': ['Automated Text Message-Based Navigation', 'Text Message-Based Navigation'], 'description': 'Receive interactive text messaging.', 'armGroupLabels': ['Health services research (text messages, smart pill bottle)']}, {'name': 'Behavioral, Psychological or Informational Intervention', 'type': 'OTHER', 'description': 'Receive medication reminders via smart pill bottle', 'armGroupLabels': ['Health services research (text messages, smart pill bottle)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Health services research (text messages, smart pill bottle)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Health services research (text messages, smart pill bottle)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}