A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Kessler-6 Psychological Distress Scale Score
研究概览
简要总结
This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.
The names of the intervention groups in this research study are:
- Usual supportive care
- PediCARE + usual supportive care
详细描述
This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.
Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance.
Participation in this research study is expected to last 6-months.
It is expected about 130 people will participate in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a new diagnosis of high-risk neuroblastoma.
- •Patient must be enrolled on APEC14B1 and must have consented to future contact on APEC14B
- •Patient must be enrolled on ANBL
- •Patient aged 0-17 years at the time of consent to ANBL
- •Patient must have opted-in to embedded optional ANBL2131 Household Survey.
- •Family screened positive for HMH or low-income on ANBL2131 Household Survey. *
- •Patient has not yet initiated Induction Cycle 3 on ANBL
- •Patient being treated at a U.S. site.
- •Patients of all languages are eligible to participate.
- •Eligibility based on Household Survey will be determined by central study team review. HMH exposure will be operationalized as the report of at least one of the following four concrete resource insecurities: (1) Food insecurity, (2) Housing Insecurity, (3) Utility Insecurity, (4) Transportation Insecurity. Low-income will be defined as reported annual household income of less than 200% federal poverty level (FPL).
排除标准
- •Patient has transferred to ANBL1531 Arm E.
结局指标
主要结局
Change in Kessler-6 Psychological Distress Scale Score
时间窗: At baseline and 3 months
As measured by the Kessler-6 Psychological Distress Scale (K6), a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores \> or = 7 suggest "high" distressed and those \> or = 13 meet criteria for serious or debilitating psychological distress. A t-test of differences in mean change scores of parent/guardian psychological distress from T1 (baseline) to T2 (3 months) will be used to compare across PediCARE and usual supportive care arms. The distribution of parent psychological distress scores across PediCARE and usual supportive care arms will also be descriptively characterized. The descriptive analyses will be intention-to-treat, defined as all randomized participants with at least one post-baseline contact or follow-up measure.
次要结局
- Proportion of Enrolled Participants (Feasibility)(5 years)
- Change in Mean Household Material Hardship (HMH) Score(At baseline and 3-months)
研究者
Kira Bona, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute