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Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

17. maj 2011 opdateret af: Fred Hutchinson Cancer Center

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Oregon Health and Science University
    • Washington
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
  • Schweiz
      • Basel, Schweiz, CH-4031
        • Clinical Cancer Research Center at University Hospital Basel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fred Hutchinson Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Roland Walter, MD, PhD, Fred Hutchinson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

13. februar 2009

Først indsendt, der opfyldte QC-kriterier

13. februar 2009

Først opslået (Skøn)

16. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2011

Sidst verificeret

1. maj 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2300.00
  • P30CA015704 (U.S. NIH-bevilling/kontrakt)
  • FHCRC-2300.00
  • IR 6845
  • CDR0000631997 (Registry Identifier: PDQ)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myelodysplastiske syndromer

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Narkotikainterventioner

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