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Spots Global Cancer Trial Database for Home or Away From Home - Descriptive Interviews (Aim 2)

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Trial Identification

Brief Title: 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 ID: NCT02794207

Interventions

Study Description

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

Minimum Age: 8 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Lucile Packard Children's Hospital, Palo Alto, California, 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 Hospital of Michigan, Detroit, Michigan, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Medical Center of Dallas, Dallas, Texas, United States

Texas Children's Hospital, Houston, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

Seattle Children's Hospital, Seattle, Washington, United States

Contact Details

Name: Richard Aplenc, MD, PhD

Affiliation: Children's Hospital of Philadelphia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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