Pediatric Acute Myeloid Leukemia
Conditions
Keywords
Pediatric, Cancer, AML, Qualitative Interview
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
Primary Children's Hospital
Texas Children's Cancer Center
Children's Healthcare of Atlanta
C.S. Mott Children's Hospital
Children's Medical Center Dallas
Arkansas Children's Hospital Research Institute
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital of Michigan
Lucile Packard Children's Hospital
Seattle Children's Hospital
Children's Hospital of Philadelphia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 22 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers. | One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes. | Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Patients who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided). | 32 |
| Caregivers Caregivers who participated in a qualitative interview about their experience with AML. One qualitative, semi-structured interview was conducted. Each interview lasted approximately 30-45 minutes and may be audio recorded (if consent is provided). | 0 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Patients |
|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 23 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants |
| Age, Continuous | 14.4 years STANDARD_DEVIATION 6.54 | 14.4 years STANDARD_DEVIATION 6.54 |
| Region of Enrollment United States | 32 participants | 32 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.
Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.
Time frame: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.
Population: All participants (patients and caregivers) who participated in the semi-structured interviews. 3 key, novel themes were identified across these interviews.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers. | 3 key themes identified |