Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
154 participants
OBSERVATIONAL
2016-09-30
2019-07-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
2. Patients with Acute Promyelocytic Leukemia (APML)
3. Patients undergoing stem cell transplant (SCT)
4. Patients receiving reduced intensity frontline chemotherapy
ALL
Yes
Sponsors
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Children's Healthcare of Atlanta
OTHER
C.S. Mott Children's Hospital
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Arkansas Children's Hospital Research Institute
OTHER
Children's Medical Center Dallas
OTHER
Baylor College of Medicine
OTHER
Primary Children's Hospital
OTHER
Children's Hospital of Michigan
OTHER
Lucile Packard Children's Hospital
OTHER
St. Jude Children's Research Hospital
OTHER
Seattle Children's Hospital
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Alfred I. duPont Hospital for Children
OTHER
Children's Hospital Colorado
OTHER
Dana-Farber Cancer Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Richard Aplenc, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-012103
Identifier Type: -
Identifier Source: org_study_id