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

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.

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Key information

Conditions

Pediatric Acute Myeloid Leukemia Neoplasms

Age range

8 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.

Time frame: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.

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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago
Arkansas Children's Hospital Research Institute
C.S. Mott Children's Hospital
Children's Healthcare of Atlanta
Children's Hospital of Michigan
Children's Medical Center Dallas
Lucile Packard Children's Hospital
Patient-Centered Outcomes Research Institute
Primary Children's Hospital
Seattle Children's Hospital
Texas Children's Cancer Center

Registry information

Official study title

Home or Away From Home: Patient-Centered Outcomes Related to the Management of Neutropenia Which Are Most Important to Children With AML and Their Caregivers

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jun 9, 2016
Registry last updated: Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed