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

NCT ID: NCT00844441

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Study Design

• Primary Study Purpose: HEALTH_SERVICES_RESEARCH

Interventions

medical chart review

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Fred Hutchinson Cancer Research Center

Principal Investigators

Roland Walter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Oregon Health and Science University

Portland, Oregon, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Clinical Cancer Research Center at University Hospital Basel

Basel, , Switzerland

Countries

United States; Switzerland

References

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.

Reference Type: DERIVED

PMID: 21393334 (View on PubMed)

Other Identifiers

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHCRC-2300.00

Identifier Type: -

Identifier Source: secondary_id

IR 6845

Identifier Type: -

Identifier Source: secondary_id

CDR0000631997

Identifier Type: REGISTRY

Identifier Source: secondary_id

2300.00

Identifier Type: -

Identifier Source: org_study_id