A Randomized Phase II Trial Evaluation of the Addition of the Resource Intervention to Support Equity (RISE) to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 7
- 主要终点
- Household Material Hardship (HMH) Score Reduction Rate
研究概览
简要总结
The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity [Pediatric RISE]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes.
Participants will be randomized to receive one of the following for 6-months:
- Usual supportive care alone or
- Usual supportive care plus Pediatric RISE
详细描述
This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.
Participation in this research study is expected to last for about 6-months.
It is expected that about 84 participants will take part 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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances.
- •Patient newly diagnosed with high-risk neuroblastoma
- •Patient has established care at study site and initiated cancer-directed therapy
- •Patient has not yet initiated Induction Cycle 3
- •Patient aged 0-17 years at the time of consent
- •Parent/guardian screened positive for self-reported low-income (<200% Federal Poverty) *
- •Family primary residence in MA, PA, IL, CA, WA, CT, GA, WI and OH
- •Both patients co-enrolled on ANBL2131 or those receiving standard of care therapy at their center are eligible to participate
- •Patients of all languages are eligible to participate
排除标准
- •Foreign national family receiving care as an Embassy-pay patient.
- •Child or household member receiving SSI
研究组 & 干预措施
Arm 1: RISE Intervention + Usual Supportive Care
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and Household Material Hardship (HMH) severity score. Participant parents/guardians will complete:
- Orientation visit in-person, by phone, or virtually with survey
- Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams
- Meeting with a benefits counselor by phone or virtually and follow up meetings if needed
- Fixed amount of cash assistance 2x monthly
- 3 months survey
- 6 month survey
干预措施: RISE Intervention (Behavioral)
Arm 2: Usual Supportive Care
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity score. Participant parents/guardians will complete:
- Orientation visit in-person, by phone, or virtually with survey
- Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams
- 3 month survey
- 6 month survey
结局指标
主要结局
Household Material Hardship (HMH) Score Reduction Rate
时间窗: Baseline (T1) and 6-months (end-intervention; T3)
HMH score reduction rate is defined as the proportion of patients achieving at least 1 domain reduction in (food, housing, utility or transportation insecurity). HMH scores range from 0 to 4, with scores of 0 indicating no hardship (unexposed) and scores of 1-4 indicating the presence of hardship (exposed). Patients who are unexposed to HMH at baseline (HMH score of 0) are excluded from the analysis.
次要结局
- Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)(3-months (end-of-induction; T2) and 6-months (end-intervention; T3))
- Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months(Baseline (T1) and 6-months (end-intervention; T3))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months(Baseline (T1) and 6-months (end-intervention; T3))
研究者
Kira Bona, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute