Home Away From Home - Quality of Life Surveys

NCT02777021 | Completed Results

• 1 other identifier: 15-012103
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 15

Brief Summary

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. Infectious complications are the leading cause of treatment related mortality among AML patients, but 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 and their caregivers.

Conditions

Pediatric Acute Myeloid Leukemia

Keywords

Pediatric; Acute Myeloid Leukemia; Quality of Life; Neutropenia Management; Patient Centered Outcomes; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management

  1 Course of Chemotherapy (Approximately 30-40 days). The primary outcome of interest was patient health-related quality of life (HRQOL) measured using the acute PedsQL™ 4.0 Generic Core Scales.31 These scales use a 7-day time frame. The multidimensional assessment includes items in four domains: physical functioning, emotional functioning, social functioning, and school functioning. Respondents document responses to each question using a 5-point Likert scale anchored by never a problem (0) to almost always a problem (4). PedsQL™ items were reverse scored and linearly transformed to a scale of 0 to 100 such that higher scores reflect better HRQOL.

  PedsQL assessments were administered at two points - at the start of the study-contributed chemotherapy course prior to the patient becoming neutropenic (baseline) and again within the period between neutropenia resolution (follow-up); follow-up reported.

Secondary Outcomes (1)

• Responses From Structured Patient-centered Outcome Surveys

  1 Course of Chemotherapy (Approximately 30-40 days)

Study Arms (2)

Early Discharge Patients

Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.

Inpatient Management Patients

Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include all AML patients who are receiving a planned chemotherapy course at any of the fifteen pediatric institutions across the US between June 1, 2016 and December 31, 2019. Patients discharged within 3 days after chemotherapy completion will be categorized as 'early discharge' to outpatient management during neutropenia. Patients remaining in the hospital more than 3 days after chemotherapy completion will be categorized as inpatient management. Caregivers of these patients will also be included.

You may qualify if:

• Participants will be enrolled as patient-caregiver dyads. The patient must be:
• Less than 19 years of age at diagnosis.
• Patient is English or Spanish literate.
• Receiving chemotherapy for AML between June 1, 2016 and December 31, 2019.
• Participants will be enrolled as patient-caregiver dyads. The caregiver must be:
• English or Spanish literate.
• The legal guardian of a patient receiving chemotherapy for AML between June 1, 2016 and December 31, 2019.
• Parental/caregiver informed consent and, if appropriate, child assent.

You may not qualify if:

• Patients being treated for relapsed AML
• Patients with Acute Promyelocytic Leukemia (APML)
• Patients undergoing stem cell transplant (SCT)
• Patients receiving reduced intensity frontline chemotherapy

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Healthcare of Atlanta: collaborator
• C.S. Mott Children's Hospital: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Arkansas Children's Hospital Research Institute: collaborator
• Children's Medical Center Dallas: collaborator
• Baylor College of Medicine: collaborator
• Primary Children's Hospital: collaborator
• Children's Hospital of Michigan: collaborator
• Lucile Packard Children's Hospital: collaborator
• St. Jude Children's Research Hospital: collaborator
• Seattle Children's Hospital: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Alfred I. duPont Hospital for Children: collaborator
• Children's Hospital Colorado: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (15)

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 Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Nemours/Alfred I DuPont Hospital for Children

Wilmington, Delaware, 19803, 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

Dana-Farber Cancer Institute/Boston Children's Hospital

Boston, Massachusetts, 02215, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, 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

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

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 16, 2016
• First Posted: May 19, 2016
• Study Start: September 1, 2016
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: December 23, 2019
• Results First Posted: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)