Acute Myeloid Leukemia Clinical Trial

Home or Away From Home – Descriptive Interviews (Aim 2)

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

To be enrolled in this study, patients must be:

A male or female between 8 and 22 years of age
Have a diagnosis of AML
Be either within 6-12 months of completion of the second course of chemotherapy for AML OR out of AML therapy for up to 3 years

To be enrolled in this study, caregivers must be:

A male or female 18 years of age or older
Be the parent/legal guardian of a child that meets the inclusion criteria detailed above (#1) OR
Be the parent/legal guardian of a male or female child younger than 8 years of age with AML and who is within 6-12 months of completion of their second course of chemotherapy
Be the parent/legal guardian of a male or female child younger than 8 years of age with AML and who is out of AML therapy for up to 3 years
Parental/guardian informed consent and, if appropriate, child assent.

Exclusion Criteria:

1) None

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

86

Study ID:

NCT02794207

Recruitment Status:

Completed

Sponsor:

Children's Hospital of Philadelphia

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There are 11 Locations for this study

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Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
Lucile Packard Children's Hospital
Palo Alto California, 94304, United States
Children's Healthcare of Atlanta
Atlanta Georgia, 30322, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago Illinois, 60611, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Medical Center of Dallas
Dallas Texas, 75235, United States
Texas Children's Hospital
Houston Texas, 77030, United States
Primary Children's Hospital
Salt Lake City Utah, 84132, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

86

Study ID:

NCT02794207

Recruitment Status:

Completed

Sponsor:


Children's Hospital of Philadelphia

How clear is this clinincal trial information?

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