NCT00844441已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Death rate in patients discharged after completion of induction chemotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Health Services Research
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of one of the following:
- •Myelodysplastic syndromes
- •Acute myeloid leukemia (AML)
- •No acute promyelocytic leukemia with t(15;17)(q22;q12), PML/RAR, or other variants
- •Planning to undergo AML-like intensive induction chemotherapy (e.g., "7+3" or regimen with similar or higher intensity) for untreated or relapsed disease within 1 week after study entry OR has started therapy within the past 72 hours
- •PATIENT CHARACTERISTICS:
- •No hypersensitivity or allergy to fluoroquinolones, triazoles, or acyclovir
- •ECOG/WHO/ZUBROD performance status 0-1*
- •Total bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is thought to be due to Gilbert's syndrome or hemolysis)*
- •AST and ALT ≤ 1.5 times ULN*
- •Serum creatinine ≤ 1.5 times ULN*
- •No clinical evidence of congestive heart failure*
- •No active bleeding*
- •Not refractory to platelet transfusions (e.g., due to HLA-alloimmunization)*
- •No requirement for IV antimicrobial therapy*
- •Agrees to undergo close follow-up that includes ≥ 3 visits per week at the Seattle Cancer Care Alliance (SCCA)*
- •Has a confirmed reliable caregiver and transportation*
- •Confirmed temporary or permanent residency within a 30-minute commute from the University of Washington (UW) Medical Center/SCCA*
- •Has identified a UW/SCCA hematologist/oncologist who is willing to care for the patient in the outpatient clinic* NOTE: *Additional criteria for early discharge from the hospital
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
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
次要结局
未报告次要终点
研究者
研究点 (3)
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