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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 15
- 主要终点
- Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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,
- •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,
- •Parental/caregiver informed consent and, if appropriate, child assent.
排除标准
- •Patients being treated for relapsed AML
- •Patients with Acute Promyelocytic Leukemia (APML)
- •Patients undergoing stem cell transplant (SCT)
- •Patients receiving reduced intensity frontline chemotherapy
结局指标
主要结局
Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management
时间窗: 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.
次要结局
- Responses From Structured Patient-centered Outcome Surveys(1 Course of Chemotherapy (Approximately 30-40 days))