Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
NCT ID: NCT01235572
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2010-12-31
2014-07-31
Brief Summary
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Detailed Description
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I. Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy.
SECONDARY OBJECTIVES:
I. Compare the costs incurred by patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.
II. Compare resource utilization (transfusions, etc.) in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after blood count recovery.
III. Compare the quality of life in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.
OUTLINE:
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a registered nurse (RN), physician assistant (PA), or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
After completion of study, patients are followed up for 1 month.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
standard follow-up care
Undergo early discharge and standard outpatient care
medical chart review
Undergo early discharge and standard outpatient care
quality-of-life assessment
Ancillary studies
Interventions
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standard follow-up care
Undergo early discharge and standard outpatient care
medical chart review
Undergo early discharge and standard outpatient care
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is planned to start such therapy within 1 week
* Provide signed written informed consent
* Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or subsequent salvage therapy)
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Roland Walter
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2012-03028
Identifier Type: REGISTRY
Identifier Source: secondary_id
2449.00
Identifier Type: OTHER
Identifier Source: secondary_id
2449.00
Identifier Type: -
Identifier Source: org_study_id
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