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

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ClinicalTrials.gov Identifier: NCT02794207
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Primary Children's Hospital
Texas Children's Cancer Center
Children's Healthcare of Atlanta
C.S. Mott Children's Hospital
Children's Medical Center Dallas
Arkansas Children's Hospital Research Institute
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital of Michigan
Lucile Packard Children's Hospital
Seattle Children's Hospital
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease
Pediatric Acute Myeloid Leukemia

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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 3, 2017


Group/Cohort
Participants
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
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794207


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Children's Hospital of Philadelphia
Patient-Centered Outcomes Research Institute
Primary Children's Hospital
Texas Children's Cancer Center
Children's Healthcare of Atlanta
C.S. Mott Children's Hospital
Children's Medical Center Dallas
Arkansas Children's Hospital Research Institute
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital of Michigan
Lucile Packard Children's Hospital
Seattle Children's Hospital
Investigators
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Principal Investigator: Richard Aplenc, MD, PhD Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02794207    
Other Study ID Numbers: 15-012082
First Posted: June 9, 2016    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).
Keywords provided by Children's Hospital of Philadelphia:
Pediatric
Cancer
AML
Qualitative Interview