Clinical trial · Observational
Home Away From Home - Quality of Life Surveys
Home or Away From Home: Comparing Patient and Caregiver Reported Quality of Life (QoL) and Other Patient-centered Outcomes for Inpatient Versus Outpatient Management of Neutropenia in Children With AML
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Early Discharge Patients
- description
- Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
- label
- Inpatient Management Patients
- description
- Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
Primary outcomes (1)
- measure
- Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management
- timeFrame
- PedsQL assessments were administered at two points - at the start of the study-contributed chemotherapy course prior to the patient becoming neutropenic (baseline) and again within the period between neutropenia resolution (follow-up); follow-up reported.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 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. 3. Parental/caregiver informed consent and, if appropriate, child assent. Exclusion Criteria: 1. Patients being treated for relapsed AML 2. Patients with Acute Promyelocytic Leukemia (APML) 3. Patients undergoing stem cell transplant (SCT) 4. Patients receiving reduced intensity frontline chemotherapy
References
Publications (0)
Data not yet available