Clinical Trial: Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML

Brief Summary: This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

II. 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.

III. 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:

Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a registered nurse (RN), physician assistant (PA), or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.

After completion of study, patients are followed up for 1 month.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy [ Time Frame: Up to day 35 ]

A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.


Original Primary Outcome: Early death rate in patients discharged after completion of intensive induction or salvage chemotherapy (Arm A) and patients discharged after completion of consolidation chemotherapy (Arm B). [ Time Frame: Within 75 days from date of re-evaluation ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Costs incurred by patients discharged early after induction or salvage chemotherapy (Arm A) and patients discharged after consolidation chemotherapy (Arm B). [ Time Frame: Within 45 days from date of re-evaluation ]
  • Resource utilization by patients discharged early after induction or salvage chemotherapy (Arm A) and patients discharged after consolidation chemotherapy (Arm B). [ Time Frame: Within 45 days from date of re-evaluation ]
  • Quality of life of patients discharged early after induction or salvage chemotherapy (Arm A) and patients discharged after consolidation chemotherapy (Arm B). [ Time Frame: Within 45 days from date of re-evaluation ]


Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: November 4, 2010
Date Started: December 2010
Date Completion:
Last Updated: February 5, 2015
Last Verified: February 2015