NCT Number: NCT00844441
Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Clinical Cancer Research Center at University Hospital Basel, Basel, Switzerland
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Questionnaire Administration
Otherquality-of-life assessment
ProcedurePrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Fred Hutchinson Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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
Important dates
- Study start
- 2008
- Primary completion
- 2010
- Study completion
- 2011
- First posted
- Feb 16, 2009
- Registry last updated
- May 19, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
NCT00454480
Anemia, Anemia, Refractory
Basingstoke, England, United Kingdom
View Trial DetailsDecitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders
NCT00114257
Blood Coagulation Disorders, Blood Platelet Disorders
Houston, Texas, United States
View Trial Details3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
NCT00077558
Anemia, Anemia, Refractory
Atlanta, Georgia, United States
View Trial DetailsChemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
NCT00005092
Blast Crisis, Blood Protein Disorders
Chicago, Illinois, United States
View Trial Details