N/A
N=86
Home or Away From Home - Descriptive Interviews (Aim 2)
Pediatric Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02794207 ↗Enrolled (actual)
86
Serious AEs
—
Results posted
Jan 2020
Primary outcome: Primary: Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers. — 3 key themes identified
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers. |
3 | — |
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.
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
- None
Data sourced from ClinicalTrials.gov (NCT02794207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.