Clinical trial NCT02794207: Home or Away From Home - Descriptive Interviews (Aim 2)
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Acute Myeloid Leukemia
Keywords: Pediatric
Cancer
AML
Qualitative Interview
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Primary Children's Hospital
name: Texas Children's Cancer Center
name: Children's Healthcare of Atlanta
name: C.S. Mott Children's Hospital
name: Children's Medical Center Dallas
name: Arkansas Children's Hospital Research Institute
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Children's Hospital of Michigan
name: Lucile Packard Children's Hospital
name: Seattle Children's Hospital
First posted: 2016-06-09
Enrollment: 86
Sex: ALL
Minimum age (years): 8
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of patients who are less than 19 years of age at the time of diagnosis (and their caregivers) receiving or having received chemotherapy for AML.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.
timeFrame: One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Richard Aplenc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: