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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00844441
First received: February 13, 2009
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Leukemia
Myelodysplastic Syndromes
Other: medical chart review
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Death rate in patients discharged after completion of induction chemotherapy [ Designated as safety issue: No ]
  • Rate of successful discharge of patients who meet medical discharge criteria [ Designated as safety issue: No ]
  • Costs associated with outpatient vs inpatient treatment [ Designated as safety issue: No ]
  • Medical resources used with outpatient vs inpatient treatment [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844441

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Switzerland
Clinical Cancer Research Center at University Hospital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Roland Walter, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roland Walter, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00844441     History of Changes
Other Study ID Numbers: 2300.00, P30CA015704, FHCRC-2300.00, IR 6845, CDR0000631997
Study First Received: February 13, 2009
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute eosinophilic leukemia
adult acute monocytic leukemia (M5b)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
acute myeloid leukemia with multilineage dysplasia following myelodysplastic syndrome
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on August 25, 2014