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

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
medical chart review
questionnaire administration
quality-of-life assessment
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Leukemia focused on measuring 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)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science University
  • Fred Hutchinson Cancer Research Center
  • Clinical Cancer Research Center at University Hospital Basel

Outcomes

Primary Outcome Measures

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 Outcome Measures

Full Information

First Posted
February 13, 2009
Last Updated
May 17, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00844441
Brief Title
Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
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)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Death rate in patients discharged after completion of induction chemotherapy
Title
Rate of successful discharge of patients who meet medical discharge criteria
Title
Costs associated with outpatient vs inpatient treatment
Title
Medical resources used with outpatient vs inpatient treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Walter, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Clinical Cancer Research Center at University Hospital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21393334
Citation
Walter RB, Lee SJ, Gardner KM, Chai X, Shannon-Dorcy K, Appelbaum FR, Estey EH. Outpatient management following intensive induction chemotherapy for myelodysplastic syndromes and acute myeloid leukemia: a pilot study. Haematologica. 2011 Jun;96(6):914-7. doi: 10.3324/haematol.2011.040220. Epub 2011 Mar 10.
Results Reference
derived

Learn more about this trial

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

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