Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
Condition: Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); 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 Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

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 description: 
      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.
    

Intervention name(s): standard follow-up care; medical chart review; quality-of-life assessment
Intervention type(s): Procedure; Other; Procedure
Intervention description(s): Undergo early discharge and standard outpatient care; Undergo early discharge and standard outpatient care; Ancillary studies
Other intervention name(s): chart review; quality of life assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Acute myeloid leukemia with multilineage dysplasia following myelodysplastic syndrome; Adult acute eosinophilic leukemia; Adult acute basophilic leukemia; De; novo myelodysplastic syndromes; Secondary myelodysplastic syndromes; Untreated adult acute myeloid leukemia