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

NCT02794207 | Completed Results

• 1 other identifier: 15-012082
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 11

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.

Conditions

Pediatric Acute Myeloid Leukemia

Keywords

Pediatric; Cancer; AML; Qualitative Interview

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 8 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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 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.

You may not qualify if:

• \) None

Sponsors & Collaborators

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

Study Sites (11)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Richard Aplenc
• Organization: Children's Hospital of Philadelphia

aplenc@email.chop.edu

267-426-7252

Study Officials

• Richard Aplenc, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: June 9, 2016
• Study Start: August 1, 2015
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)