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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844441
• Other study ID #: 2300.00
• Secondary ID: P30CA015704FHCRC
• Status: Completed
• Phase: N/A
• First received: February 13, 2009
• Last updated: May 17, 2011
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• medical chart review

• questionnaire administration

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Switzerland	Clinical Cancer Research Center at University Hospital Basel	Basel
United States	Oregon Health and Science University	Portland	Oregon
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate in patients discharged after completion of induction chemotherapy			No
Primary	Rate of successful discharge of patients who meet medical discharge criteria			No
Primary	Costs associated with outpatient vs inpatient treatment			No
Primary	Medical resources used with outpatient vs inpatient treatment			No