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LeukemiaNCT00844441

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

A study testing medical chart review, questionnaire administration and quality-of-life assessment in people with Leukemia and Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
medical chart review, questionnaire administration and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
96 participants
Where
3 sitesin 2 countries
Study dates
Dec 2008to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

Switzerland1 site

  • Clinical Cancer Research Center at University Hospital Basel

    Basel, CH-4031

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
medical chart review, questionnaire administration, quality-of-life assessment
Keywords
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)
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Megakaryoblastic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medical chart reviewOther

  • questionnaire administrationOther

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death rate in patients discharged after completion of induction chemotherapy

  2. Rate of successful discharge of patients who meet medical discharge criteria

  3. Costs associated with outpatient vs inpatient treatment

  4. Medical resources used with outpatient vs inpatient treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844441
Sponsor's protocol ID
2300.00
Other IDs
P30CA015704, FHCRC-2300.00, IR 6845, CDR0000631997
Status last verified
May 2011
First submitted
13 Feb 2009
Last updated
19 May 2011
Results posted
No

Publications

  • 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.

    PubMed 21393334

Questions about this trial

What is this clinical trial studying?

A study testing medical chart review, questionnaire administration and quality-of-life assessment in people with Leukemia and Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death rate in patients discharged after completion of induction chemotherapy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00844441, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.

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