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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Primary Children's Hospital | OTHER |
| Texas Children's Cancer Center | OTHER |
| Children's Healthcare of Atlanta |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included. | ||
| Caregivers | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes. |
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Inclusion Criteria:
To be enrolled in this study, patients must be:
To be enrolled in this study, caregivers must be:
Parental/guardian informed consent and, if appropriate, child assent.
Exclusion Criteria:
1) None
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Study population will consist of patients who are less than 19 years of age at the time of diagnosis (and their caregivers) receiving or having received chemotherapy for AML.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Aplenc, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Lucile Packard Children's Hospital |
Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included. |
| FG001 | Caregivers | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Data werenot collected for caregivers.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants (patients and caregivers) who participated in the semi-structured interviews. 3 key, novel themes were identified across these interviews. | Posted | Number | key themes identified | One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes. |
|
Adverse events were not collected while interviews were being conducted. Interviews were conducted when a patient was within 6-12 months of the completion of their second course of chemotherapy or up to 3 years out following the completion of all their frontline AML chemotherapy. The time relative to treatment, therefore, varied by family.
There is no study intervention; this is a qualitative interview study only, thus adverse events were a non-issue and not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of the participant's illness and treatment. Several close-ended questions regarding participant's thoughts on potential outcomes will also be included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Aplenc | Children's Hospital of Philadelphia | 267-426-7252 | aplenc@email.chop.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| OTHER |
| C.S. Mott Children's Hospital | OTHER |
| Children's Medical Center Dallas | OTHER |
| Arkansas Children's Hospital Research Institute | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Children's Hospital of Michigan | OTHER |
| Lucile Packard Children's Hospital | OTHER |
| Seattle Children's Hospital | OTHER |
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| 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 |
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Caregivers | One qualitative, semi-structured interview will be conducted. Each interview will last approximately 30-45 minutes and may be audio recorded (if consent is provided). Interviews will consist of several open-ended questions focusing on having the participant reflect upon past experiences with neutropenia management and the impact of their child's illness and treatment. Several close-ended questions regarding participant's thoughts on their child's potential outcomes will also be included. | 0 | 0 | 0 | 0 |
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