Home Away From Home - Quality of Life Surveys (Aim 3)
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|ClinicalTrials.gov Identifier: NCT02777021|
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
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|Condition or disease|
|Pediatric Acute Myeloid Leukemia|
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 Type :||Observational|
|Actual Enrollment :||154 participants|
|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|
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.
- 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.
- 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.
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.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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.
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.
- Patients being treated for relapsed AML
- Patients with Acute Promyelocytic Leukemia (APML)
- Patients undergoing stem cell transplant (SCT)
- Patients receiving reduced intensity frontline chemotherapy
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
|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|
|Principal Investigator:||Richard Aplenc, MD, PhD||Children's Hospital of Philadelphia|
Documents provided by Children's Hospital of Philadelphia:
|Responsible Party:||Children's Hospital of Philadelphia|
|Other Study ID Numbers:||
|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.|
Acute Myeloid Leukemia
Quality of Life
Patient Centered Outcomes
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type