Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06082804
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2023-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'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': 'D011216', 'term': 'Practice Management, Medical'}], 'ancestors': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 patients will be included, these patients will be randomized into two groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the role of the advanced practice nurse in early detection of grade I-II adverse events during care and management of Chronic Myeloid Leukemia compared to standard of care (hematologist only).', 'timeFrame': 'Inclusion and 6 months', 'description': 'Grade I-II adverse events rate'}], 'secondaryOutcomes': [{'measure': 'Evaluate the role of the advanced practice nurse in early detection of grade I-II adverse events during care and management of Chronic Myeloid Leukemia compared to standard of care (hematologist only).', 'timeFrame': '6 months and 12 months', 'description': 'Grade I-II adverse events rate'}, {'measure': "Assessment of patient's quality of life", 'timeFrame': 'Inclusion, 6 months and 12 months', 'description': 'European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 : EORTC-QLQ-C30 (composed of both multi-item scales and single-item measures : 5 functional scales, 3 symptom scales, 6 single items and a global health status. All of the the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. ie : A high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high quality of life but a high score for a symptom scale or a single item represents a high level of symptomatology).'}, {'measure': "Assessment of patient's compliance to treatment", 'timeFrame': '6 months and 12 months', 'description': 'GIRERD questionnaire (measures range from 0 to 6. A low score represents a high level of compliance).'}, {'measure': 'Grade > II adverse events rates', 'timeFrame': '6 months and 12 months'}, {'measure': 'Hospitalization rate', 'timeFrame': '6 months and 12 months'}, {'measure': 'Treatment discontinuation rate and/or treatment change rate', 'timeFrame': 'Every medical consultation, from inclusion to 12 months'}, {'measure': 'Consultation time comparison between advanced practice nurse and hematologist', 'timeFrame': 'Every medical consultation, from inclusion to 12 months'}, {'measure': 'Molecular response rate assessment', 'timeFrame': '6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Practice Nursing', 'Quality of life', 'Adverse event'], 'conditions': ['Chronic Myelogenous Leukemia - Chronic Phase']}, 'descriptionModule': {'briefSummary': "Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old.\n\nTyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions.\n\nOptimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML.\n\nThe Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals.\n\nAt international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance.\n\nIn France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* CML patient in chronic phase, eligible for oral therapy.\n* Newly diagnosed CML and/or initiating oral therapy :\n\n * Patient changing treatment for non-response or loss of therapeutic response or toxicities, on the condition that these toxicities are resolved or grade I maximum at the time of inclusion.\n * Newly start of oral therapy.\n* Patient eligible to a follow-up by an advanced practice nurse.\n* Patient capable to understand french and complete a questionnaire.\n\nExclusion Criteria:\n\n* Patient that had a follow-up \\> 3 months by an advanced practice nurse for CML before inclusion.\n* Patient changing treatment for toxicities, if these toxicities are still \\> grade I at inclusion.\n* Patient enrolled in another interventional research protocol for CML.\n* Pregnant women.\n* Patient under legal protection, deprived of liberty or unable to be included in a research protocol.'}, 'identificationModule': {'nctId': 'NCT06082804', 'acronym': 'IPA-LMC', 'briefTitle': "Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Henri Duffaut - Avignon'}, 'officialTitle': "Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia", 'orgStudyIdInfo': {'id': 'IPA-LMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: IPA group', 'description': 'Patients in arm A are followed by the advanced practice nurse and the hematologist.', 'interventionNames': ['Other: APN and medical management', 'Behavioral: Quality of life assessment', 'Behavioral: Treatment compliance assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: Control group', 'description': 'Patients in arm B are followed by the hematologist only (standard of care).', 'interventionNames': ['Other: Medical management', 'Behavioral: Quality of life assessment', 'Behavioral: Treatment compliance assessment']}], 'interventions': [{'name': 'APN and medical management', 'type': 'OTHER', 'description': 'Patients are followed by the advanced practice nurse and the hematologist.', 'armGroupLabels': ['A: IPA group']}, {'name': 'Medical management', 'type': 'OTHER', 'description': 'Patients are followed by the hematologist only (standard of care).', 'armGroupLabels': ['B: Control group']}, {'name': 'Quality of life assessment', 'type': 'BEHAVIORAL', 'description': 'EORTC-QLQ-C30 questionnaire', 'armGroupLabels': ['A: IPA group', 'B: Control group']}, {'name': 'Treatment compliance assessment', 'type': 'BEHAVIORAL', 'description': 'GIRERD questionnaire', 'armGroupLabels': ['A: IPA group', 'B: Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avignon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marilyne Grinand, PhD', 'role': 'CONTACT', 'email': 'grinand.marilyne@ch-avignon.fr', 'phone': '(+33)432759392'}, {'name': 'Christine Tosello, APN', 'role': 'CONTACT'}, {'name': 'Borhane Slama, MD', 'role': 'CONTACT'}, {'name': 'Hacène Zerazhi, MD', 'role': 'CONTACT'}, {'name': 'Safia Chebrek, MD', 'role': 'CONTACT'}, {'name': 'Thierry Takam, MD', 'role': 'CONTACT'}], 'facility': "Centre Hospitalier d'Avignon, Hôpital Henri Duffaut", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}], 'centralContacts': [{'name': 'Marilyne Grinand, PhD', 'role': 'CONTACT', 'email': 'grinand.marilyne@ch-avignon.fr', 'phone': '(+33)432759392'}, {'name': 'Christine Tosello, APN', 'role': 'CONTACT', 'email': 'ihuel.christine@ch-avignon.fr', 'phone': '(+33)432759348'}], 'overallOfficials': [{'name': 'Christine Tosello, APN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Henri Duffaut - Avignon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}