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Clinical Trials/NCT00844441
NCT00844441
Completed
Not Applicable

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

Fred Hutchinson Cancer Center3 sites in 2 countries96 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Fred Hutchinson Cancer Center
Enrollment
96
Locations
3
Primary Endpoint
Death rate in patients discharged after completion of induction chemotherapy
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

RATIONALE: Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about a patient's quality of life, use of medical services, and the cost of these services.

PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Death rate in patients discharged after completion of induction chemotherapy

Rate of successful discharge of patients who meet medical discharge criteria

Costs associated with outpatient vs inpatient treatment

Medical resources used with outpatient vs inpatient treatment

Study Sites (3)

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