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

Pediatric Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794207
• Other study ID #: 15-012082
• Status: Completed
• Start date: August 2015
• Est. completion date: January 3, 2017

Study information

• Verified date: January 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 3, 2017
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Acute Myeloid Leukemia

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Texas Children's Hospital	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (12)

Lead Sponsor

Collaborator

Children's Hospital of Philadelphia

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.	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.	One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.