Home or Away From Home - Descriptive Interviews (Aim 2)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Pediatric Acute Myeloid Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT02794207

15-012082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 8 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Participants

Description:

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

Description:

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.