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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 96
- Locations
- 6
- Primary Endpoint
- Death rate in patients discharged after completion of induction chemotherapy
Study 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Health Services Research
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported