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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00844441

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

26.9

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Other: medical chart review Other: questionnaire administration Procedure: quality-of-life assessment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97201-3098
2	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
3	Clinical Cancer Research Center at University Hospital Basel	Basel		Switzerland	CH-4031