Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Oregon
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Portland, Oregon, Förenta staterna, 97201-3098
- Oregon Health and Science University
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Washington
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Seattle, Washington, Förenta staterna, 98109-1024
- Fred Hutchinson Cancer Research Center
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-
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-
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Basel, Schweiz, CH-4031
- Clinical Cancer Research Center at University Hospital Basel
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
Vad mäter studien?
Primära resultatmått
Resultatmått |
|---|
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Death rate in patients discharged after completion of induction chemotherapy
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Rate of successful discharge of patients who meet medical discharge criteria
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Costs associated with outpatient vs inpatient treatment
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Medical resources used with outpatient vs inpatient treatment
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Roland Walter, MD, PhD, Fred Hutchinson Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- de novo myelodysplastiska syndrom
- tidigare behandlade myelodysplastiska syndrom
- sekundära myelodysplastiska syndrom
- akut myeloid leukemi hos vuxna med 11q23 (MLL) abnormiteter
- akut myeloid leukemi hos vuxna med inv(16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- återkommande akut myeloid leukemi hos vuxna
- obehandlad akut myeloid leukemi hos vuxna
- akut megakaryoblastisk leukemi hos vuxna (M7)
- vuxen akut minimalt differentierad myeloid leukemi (M0)
- akut monoblastisk leukemi hos vuxna (M5a)
- akut monocytisk leukemi hos vuxna (M5b)
- akut myeloblastisk leukemi hos vuxna med mognad (M2)
- akut myeloblastisk leukemi hos vuxna utan mognad (M1)
- akut myelomonocytisk leukemi hos vuxna (M4)
- akut basofil leukemi hos vuxna
- akut eosinofil leukemi hos vuxna
- erytroleukemi hos vuxna (M6a)
- ren erytroid leukemi hos vuxna (M6b)
- akut myeloid leukemi med multilineage dysplasi efter myelodysplastiskt syndrom
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2300.00
- P30CA015704 (U.S.S. NIH-anslag/kontrakt)
- FHCRC-2300.00
- IR 6845
- CDR0000631997 (Registeridentifierare: PDQ)
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