Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT04482894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-19', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Place of death', 'timeFrame': 'At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years', 'description': 'Location of death (ICU, inpatient floor, hospice, home)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.', 'description': 'Time from enrollment through death (for participants that die)'}, {'measure': 'Duration of hospitalizations', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Duration of hospitalizations'}, {'measure': 'Type(s) of hospitalizations', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Type(s) of hospitalizations'}, {'measure': 'Frequency of hospitalizations', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Frequency of hospitalizations'}, {'measure': 'Emergency department visits', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Frequency/Number of emergency department visits'}, {'measure': 'Hospice services use', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Dates of use of hospice services'}, {'measure': 'Transfusions', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Frequency/number and types of transfusions received'}, {'measure': 'Quality of life measure', 'timeFrame': 'At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.', 'description': 'Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life'}, {'measure': 'Code status change', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)'}, {'measure': 'Goals of Care (GOC) Discussions', 'timeFrame': 'From enrollment through participant death or study completion, an average of 2 years.', 'description': 'Whether a GOC discussion occurs while on study, and if so, date and location of discussion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Acute', 'AML, Adult', 'ALL, Adult', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.', 'detailedDescription': 'Participants in this study will be randomized to either an intervention group or a standard of care group. Participants in the intervention group will participate in regular visits with a palliative (or supportive) care specialist, while participants in the standard of care group will only see palliative care specialists if the clinician requests a referral. All participants will be asked to complete monthly questionnaires regarding their general well-being.\n\nParticipants have a greater chance of being assigned to the intervention group than to the standard of care group. On average, in every 5 people randomized, 3 will be randomized to the intervention and 2 will be randomized to standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Any of the following:\n\n 1. Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and older.\n\n OR\n 2. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.\n\n OR\n 3. Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older.\n\nRefractory AML/ALL will be defined as persistent leukemia despite two or more cycles of induction chemotherapy.\n\nRefractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML will be based on the assessment of the treating investigator.\n\nExclusion Criteria:\n\n1\\. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)'}, 'identificationModule': {'nctId': 'NCT04482894', 'briefTitle': 'Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study', 'orgStudyIdInfo': {'id': 'HSR 200133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palliative Care Intervention', 'description': "Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month.", 'interventionNames': ['Other: Palliative Care Visits']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Clinical Care', 'description': 'Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult.'}], 'interventions': [{'name': 'Palliative Care Visits', 'type': 'OTHER', 'description': 'Regular visits with a palliative (supportive) care specialist', 'armGroupLabels': ['Palliative Care Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Karen Ballen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Karen Ballen, MD', 'investigatorAffiliation': 'University of Virginia'}}}}