Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 9:44 AM
Study NCT ID:
NCT06229860
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts W/Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of adherence to TKI medication', 'timeFrame': 'Up to 1 year', 'description': 'This will be measured by Morisky Medication Adherence Scale (MMAS), an 8-item tool related to adherence behavior include forgetfulness, stopping medication because of worsening of symptoms or improvement in health condition, and inconvenience of continuing medication. Each item is scored 0 or 1 depending on whether the patient answers yes or no, with a minimum score of 0 and maximum score of 8'}, {'measure': 'Personality assessment', 'timeFrame': 'Up to 1 year', 'description': 'Patient personality will be assessed using the Mini International Personality Item Pool (mini-IPIP) questionnaire. In the mini-IPIP, each of the five factors (openness, conscientiousness, extraversion, agreeableness and neuroticism) is assessed with four items, making a total of 20 items. Each item is scored on a scale of 1 through 5, with 1 indicating "very inaccurate" and 5 corresponding to "very accurate"'}, {'measure': 'Assessment of quality of Life', 'timeFrame': 'Up to 1 year', 'description': 'This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30). EORTC QLQ C30 includes 30 items that measure global health status, functioning, and symptoms.'}, {'measure': 'Assessment of quality of Life and symptom burden', 'timeFrame': 'Up to 1 year', 'description': 'This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia -24 scales.(EROTC QLQ-CML 24). The EORTC QLQ CML 24 is a 24-item questionnaire developed exclusively to assess QoL issues in patients with CML'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Myeloid Leukemia', 'Chronic Phase Chronic Myelogenous Leukemia']}, 'descriptionModule': {'briefSummary': "This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.", 'detailedDescription': "The purpose of this pilot study is to explore the association between personality and adherence to a specific type of oral cancer medication - tyrosine kinase inhibitor (TKI) - in patients with chronic myeloid leukemia (CML). 75 individuals with chronic phase CML who are being treated with TKIs will be recruited. Consenting patients will participate in a focused interview where TKI adherence, personality type, and quality of life and symptom burden will be assessed using validated questionnaires. Information on treatment response and the treating physician's perception of TKI adherence will be obtained from the electronic health record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study populations include adult patients with CML in chronic phase (CML-CP) who are being treated with one of the four TKIs - imatinib, dasatinib, bosutinib, and nilotinib', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)\n* Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib\n* A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or\n* A member of a patient support group organized by the CML Buster Foundation\n* Do not meet any of the criteria listed under "Exclusion Requirements"\n\nExclusion Criteria:\n\n* Unable to read and speak English\n* Impaired decisional capacity to consent'}, 'identificationModule': {'nctId': 'NCT06229860', 'briefTitle': 'Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts W/Chronic Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients with Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': '3709'}, 'secondaryIdInfos': [{'id': 'UCI 23-110', 'type': 'OTHER', 'domain': 'UCI CFCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with CML in chronic phase (CML-CP)', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'In-person interview with the study coordinator to complete study questionnaire.', 'armGroupLabels': ['Adult patients with CML in chronic phase (CML-CP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mahtab Jafari, Pharm.D', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}], 'facility': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '1-877-827-8839'}, {'name': 'University of California Irvine Medical', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Mahtab Jafari, Pharm.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmaceutical Sciences & Equity Advisor', 'investigatorFullName': 'Mahtab Jafari', 'investigatorAffiliation': 'University of California, Irvine'}}}}