Pediatric Acute Myeloid Leukemia Clinical Trial
Official title:
Home or Away From Home: Patient-Centered Outcomes Related to the Management of Neutropenia Which Are Most Important to Children With AML and Their Caregivers
The primary objectives of this study are to identify what outcomes related to the management of neutropenia are most important to children with AML and their caregivers. Patients who have completed treatment for AML and their caregivers will be interviewed in order to better understand the impact of neutropenia management on children with AML and their families. The primary outcome of these interviews is to identify patient-centered outcomes related to neutropenia management to include in a subsequent comparative-effectiveness analysis. Investigators will use these data to develop a structured survey for administration to prospectively identified patients in subsequent studies.
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens
that result in periods of profound neutropenia leaving patients susceptible to severe
infectious complications. There are little clinical data to inform whether management of
neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting.
Further, no studies have been conducted that assess the impact of neutropenia management
strategy on the quality of life of pediatric patients with AML. Given that infectious
complications are the leading cause of treatment related mortality among AML patients, it is
important to identify the neutropenia management strategy that will lead to the best
clinician- and patient- identified outcomes in order to improve the care of these patients.
This is a qualitative interview study where interviews of patients and/or caregivers will be
performed. Participants will be patients less than 19 years of age at diagnosis (and their
caregivers) receiving or having received chemotherapy for AML from eleven participating
pediatric hospitals across the United States. Participants (children and caregivers) will be
interviewed in an effort to develop a survey that captures patient- and caregiver- identified
outcomes related to neutropenia management.
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