Home or Away From Home - Descriptive Interviews (Aim 2)
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 8 - 22 |
Updated: | 9/7/2018 |
Start Date: | August 2015 |
End Date: | January 3, 2017 |
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.
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.
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.
Inclusion Criteria:
1. 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
2. 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
3. Parental/guardian informed consent and, if appropriate, child assent.
Exclusion Criteria:
1) None
We found this trial at
11
sites
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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