N/A
N=154
Home Away From Home - Quality of Life Surveys
Pediatric Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02777021 ↗Enrolled (actual)
154
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management — 70.1; 68.7 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management |
70.1; 68.7 | — |
| SECONDARY Responses From Structured Patient-centered Outcome Surveys |
— | — |
Summary
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. Infectious complications are the leading cause of treatment related mortality among AML patients, but 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 and their caregivers.
Eligibility Criteria
Inclusion Criteria
- Participants will be enrolled as patient-caregiver dyads. The patient must be:
- Less than 19 years of age at diagnosis.
- Patient is English or Spanish literate.
- Receiving chemotherapy for AML between June 1, 2016 and December 31, 2019.
- Participants will be enrolled as patient-caregiver dyads. The caregiver must be:
- English or Spanish literate.
- The legal guardian of a patient receiving chemotherapy for AML between June 1, 2016 and December 31, 2019.
- Parental/caregiver informed consent and, if appropriate, child assent.
Exclusion Criteria
- Patients being treated for relapsed AML
- Patients with Acute Promyelocytic Leukemia (APML)
- Patients undergoing stem cell transplant (SCT)
- Patients receiving reduced intensity frontline chemotherapy
Data sourced from ClinicalTrials.gov (NCT02777021). 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.