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Home Away From Home - Quality of Life Surveys (Aim 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02777021
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Children's Healthcare of Atlanta
C.S. Mott Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Arkansas Children's Hospital Research Institute
Children's Medical Center Dallas
Baylor College of Medicine
Primary Children's Hospital
Children's Hospital of Michigan
Lucile Packard Children's Hospital
St. Jude Children's Research Hospital
Seattle Children's Hospital
Patient-Centered Outcomes Research Institute
Alfred I. duPont Hospital for Children
Children's Hospital Colorado
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.

Condition or disease
Pediatric Acute Myeloid Leukemia

Detailed Description:

This is a prospective observational cohort study, where the primary objective of this study is to compare patient and caregiver quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapy.

Local study investigators (pediatric oncologists and study coordinators) at each of the fifteen participating pediatric institutions will communicate on a weekly basis with their inpatient leukemia service to identify AML or MDS patients potentially eligible for study enrollment. Once identified, study personnel will review each patient for study eligibility criteria. Three visits with the patient and their caregivers will occur: a screening visit, initial survey visit, and a follow-up visit.

Screening Visit: The eligibility criteria for participation will be confirmed prior to approaching for consent. Eligible patients interested in the study will be approached for consent at any time from AML/MDS diagnosis through last day of chemotherapy in the treatment course under study. In some cases, the patient's caregivers may not be present in the hospital to provide consent. In these cases, study personnel will obtain verbal consent from the caregivers and child assent (if appropriate).

Visit 1 will occur prior to the last day of chemotherapy administration in the course. This visit will include:

  • 2 Brief demographic surveys to capture covariates unavailable in the medical record
  • Baseline health-related quality of life (HRQOL) surveys
  • A baseline financial toxicity assessment

Surveys will be administered via paper or a smart device and will last a total of 15-30 minutes per respondent. In the case that the child is 5 years of age or older, the child self-report and parent proxy-report scales will be separately administered to the child and caregiver, respectively. If the child is under 5 years of age, only the parent-proxy version will be administered. Only the caregiver completes the baseline financial toxicity assessment. We will provide a $25 gift card to each child-parent dyad upon completion of the baseline surveys

Visit 2 will occur within the period after absolute neutrophil count recovery and ideally prior to the start of the subsequent course of chemotherapy, but no later than the last day of chemotherapy in that next treatment course. This visit will include:

  • Follow-up HRQOL surveys
  • Patient-centered outcome survey developed previously from qualitative interviews of AML patients and their caregivers
  • A follow-up financial toxicity assessment

Surveys will be administered via paper or a smart device and will last a total of 15-30 minutes per respondent. In the case that the child is 5 years of age or older, the child self-report and parent proxy-report scales will be administered to the child and caregiver, respectively. If the child is under 5 years of age, only the parent-proxy version will be administered. The follow-up financial toxicity assessment and the patient-centered outcome survey are completed by the caregiver only. We will provide a $25 gift card to each child-parent dyad upon completion of the follow-up surveys.

Study Design
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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home or Away From Home: Comparing Patient and Caregiver Reported Quality of Life (QoL) and Other Patient-centered Outcomes for Inpatient Versus Outpatient Management of Neutropenia in Children With AML
Study Start Date : September 2016
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Responses From Structured Patient-centered Outcome Surveys [ Time Frame: 1 Course of Chemotherapy (Approximately 30-40 days) ]
    Information from semi-structured patient outcome surveys completed by patients and caregivers will be collected to evaluate the relationship between neutropenia management strategy (inpatient versus outpatient) and outcomes reported by patients and caregivers.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Parental/caregiver informed consent and, if appropriate, child assent.

Exclusion Criteria:

  1. Patients being treated for relapsed AML
  2. Patients with Acute Promyelocytic Leukemia (APML)
  3. Patients undergoing stem cell transplant (SCT)
  4. Patients receiving reduced intensity frontline chemotherapy
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02777021


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, Colorado
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
United States, Delaware
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
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, Massachusetts
Dana-Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States, 02215
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
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
Children's Healthcare of Atlanta
C.S. Mott Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Arkansas Children's Hospital Research Institute
Children's Medical Center Dallas
Baylor College of Medicine
Primary Children's Hospital
Children's Hospital of Michigan
Lucile Packard Children's Hospital
St. Jude Children's Research Hospital
Seattle Children's Hospital
Patient-Centered Outcomes Research Institute
Alfred I. duPont Hospital for Children
Children's Hospital Colorado
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Richard Aplenc, MD, PhD Children's Hospital of Philadelphia
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
Study Protocol and Statistical Analysis Plan  [PDF] July 1, 2019

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02777021    
Other Study ID Numbers: 15-012103
First Posted: May 19, 2016    Key Record Dates
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only aggregate and de-identified data will be shared upon appropriate request.
Keywords provided by Children's Hospital of Philadelphia:
Pediatric
Acute Myeloid Leukemia
Quality of Life
 Neutropenia Management
Patient Centered Outcomes
Chemotherapy
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms