Home Away From Home - Quality of Life Surveys

Pediatric Acute Myeloid Leukemia Clinical Trial

— Aim 3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777021
• Other study ID #: 15-012103
• Status: Completed
• Start date: September 2016
• Est. completion date: July 18, 2019

Study information

• Verified date: December 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Pediatric Acute Myeloid Leukemia

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital of Colorado	Aurora	Colorado
United States	Dana-Farber Cancer Institute/Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Texas Children's Hospital	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington
United States	Nemours/Alfred I DuPont Hospital for Children	Wilmington	Delaware

Sponsors (16)

Lead Sponsor

Collaborator

Children's Hospital of Philadelphia

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Responses From Structured Patient-centered Outcome Surveys	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.	1 Course of Chemotherapy (Approximately 30-40 days)