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

Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified July 2012 by Fred Hutchinson Cancer Research Center

First Received on November 4, 2010.  
Last Updated on July 17, 2012  
History of Changes
Sponsor: Fred Hutchinson Cancer Research Center
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01235572
  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 the safety of allowing patients to leave the hospital early, the patient’s quality of life, use of medical services, and the cost of these services associated with such a policy.

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 Phase
Leukemia
Myelodysplastic Syndromes
Other: Early hospital discharge
Other: Medical chart review
Other: Questionnaire administration
Other: Electronic billing information review
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML

Resource links provided by NLM:

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

Primary Outcome Measures:

  • Early death rate in patients discharged after completion of intensive induction or salvage chemotherapy [ Time Frame: Within 75 days from date of re-evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Costs incurred by patients discharged early after induction or salvage chemotherapy [ Time Frame: Within 45 days from date of re-evaluation ] [ Designated as safety issue: No ]
  • Resource utilization by patients discharged early after induction or salvage chemotherapy [ Time Frame: Within 45 days from date of re-evaluation ] [ Designated as safety issue: No ]
  • Quality of life of patients discharged early after induction or salvage chemotherapy [ Time Frame: Within 45 days from date of re-evaluation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Early hospital discharge

Enrollment of patients undergoing induction chemotherapy for newly diagnosed or relapsed/refractory MDS/AML
Other: Early hospital discharge

Early discharge of patients following chemotherapy for MDS/AML provided that certain medical and logistic criteria are met.

Other: Medical chart review

Review of medical records to assess resource utilization (antibiotics, ICU care, transfusions, etc)

Other: Questionnaire administration

Administration of questionnaires to obtain information on quality of life

Other: Electronic billing information review

Review of billing information to assess professional and facility charges incurred by patients enrolled on this study
Control

Enrollment of patients undergoing induction chemotherapy for newly diagnosed or relapsed/refractory MDS/AML
Other: Medical chart review

Review of medical records to assess resource utilization (antibiotics, ICU care, transfusions, etc)

Other: Questionnaire administration

Administration of questionnaires to obtain information on quality of life

Other: Electronic billing information review

Review of billing information to assess professional and facility charges incurred by patients enrolled on this study

Detailed Description:

OBJECTIVES:

Primary

Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy.

Secondary

Compare the costs incurred by patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

Compare resource utilization (transfusions, etc.) in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after blood count recovery.

Compare the quality of life in patients discharged early after induction or salvage chemotherapy with similar patients who are discharged only after their blood counts recover.

OUTLINE:

This study will enroll subjects who consent to be discharged from the study center’s inpatient service after completion of induction/salvage chemotherapy and to receive standard supportive care (e.g. transfusions, prophylactic antibiotics) as outpatients at the study center. Chemotherapy will not be administered. Rather, this protocol recommends a standardized approach by which these patients are followed and what supportive care they receive. 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 based on a set of medical and logistic early discharge criteria.

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 (MDASI) 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 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Age 18-75 years.
  • Diagnosis of MDS or AML other than APL with t(15;17)(q22;q12), (PML/RAR), or variants according to the 2008 WHO classification.
  • Will undergo AML-like intensive induction or re-induction chemotherapy within 1 week, or have started therapy within last 72 hours.

EXCLUSION CRITERION

– Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235572

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Roland B. Walter, MD, PhD     206-667-3599        
Principal Investigator: Roland B. Walter, MD, PhD            
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Roland B. Walter, MD, PhD FHCRC/UWCC
  More Information

No publications provided

Responsible Party: Roland B. Walter, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01235572    
History of Changes
Other Study ID Numbers: 2449.00, 7352
Study First Received: November 4, 2010
Last Updated: July 17, 2012
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 21, 2012

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