Pilot Study of Feasibility, Safety, and Economics of Early Discharge and Outpatient Management of Adult Patients Following Intensive Induction Chemotherapy for Myelodysplastic Syndrome and Non-APL Acute Myeloid Leukemia
OBJECTIVES:
Primary
- To compare the death rate in patients with myelodysplastic syndromes or acute myeloid
leukemia who are discharged after completion of induction chemotherapy vs those who
remain in the hospital until blood counts recover.
Secondary
- To determine the proportion of patients who meet the early discharge criteria after
completion of induction chemotherapy.
- To compare the costs incurred by patients who are discharged early vs those who are
discharged only after blood counts recover.
- To compare resource utilization (e.g., transfusions) among these patients.
- To compare the quality of life of these patients.
OUTLINE: Within 72 hours after completion of induction chemotherapy, patients are either
discharged from the hospital or remain in the hospital until their blood counts recover.
Patients receive standard supportive care after completion of induction chemotherapy either
in the hospital or as an outpatient. Outpatients are seen by a registered nurse or physician
assistant ≥ 3 times weekly and by a physician at least once weekly.
A medical chart review is conducted to obtain information about medical complications (e.g.,
neutropenic fever, documented infections, bleeding, reasons for hospitalization) and use of
medical resources. Patients complete the MDA Symptom Inventory and the EORTC QLQ-C30
questionnaire periodically to assess quality of life. Costs associated with inpatient and
outpatient care are evaluated using electronic billing information from the University of
Washington Medical Center and Seattle Cancer Care Alliance.
After completion of the study, patients are followed up for 1 month.
Interventional
Primary Purpose: Health Services Research
Death rate in patients discharged after completion of induction chemotherapy
No
Roland Walter, MD, PhD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Institutional Review Board
2300.00
NCT00844441
December 2008
March 2011
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Oregon Health and Science University | Portland, Oregon 97201 |