Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02619604
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2015-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'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'}, {'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': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey', 'timeFrame': 'Baseline, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).', 'detailedDescription': 'This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Clinician\n\n* Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network\n* Participant treats patients with CLL\n* Participant is willing to participate in the educational component of this project\n\nInclusion Criteria: Patient\n\n* Patient has a diagnosis of Chronic Lymphocytic Leukemia\n* Patient is over the age of 18\n* Patient is being treated at a Duke Cancer Network affiliate site,\n* Patient is expected to see their physician or another member of their care team at least 3 times annually.\n* Signed informed consent\n\nExclusion Criteria: Clinician\n\n* None\n\nExclusion Criteria: Patient\n\n* Patient is Non-English speaking\n* Patient diagnosed with CLL \\< 60 days ago'}, 'identificationModule': {'nctId': 'NCT02619604', 'acronym': 'Med-IQ CLL', 'briefTitle': 'A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'Pro00063975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinician education', 'interventionNames': ['Other: Education Intervention']}], 'interventions': [{'name': 'Education Intervention', 'type': 'OTHER', 'description': 'Education interventions will be delivered sporadically within the 6-month window between the time the clinician completes the pre-survey and when he/she completes the post-survey. Interventions consist of e-brief publications, teleconferences with project faculty, and evidence based resources.', 'armGroupLabels': ['Clinician education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Network', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Linda Sutton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Med-IQ', 'class': 'INDUSTRY'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}