Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Participant Consent Rate
研究概览
简要总结
The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.
The names of the study groups in this research study are:
- PediRISE Program Group
- Usual Care Group
详细描述
This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with (1) a new diagnosis of childhood cancer at DFCI and Columbia University and among poverty-exposed families with a child with cancer and (2) receiving hematopoietic stem cell transplant (HSCT) at DFCI, Columbia University, or the University of California - San Francisco (UCSF). Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group.
Study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires.
Participation in this study will last for about 6-months.
It is expected that about 40 pediatric participants with parents/guardians will take part in this research study.
This study is being supported by grants from the American Cancer Society and the Children's Cancer Research Fund.
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
- •Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- •Child diagnosed with de novo cancer
- •Child has established care at a study site and initiated cancer directed therapy in the prior 2-months
- •Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan
- •Child is <18 years at time of enrollment
- •Parent/guardian screened positive for self-reported low-income (<200% FPL)
- •Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- •Provider approval for permission to approach
- •Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- •Child undergoing allogeneic HSCT for treatment of cancer
- •Child has established care at a study site and is between 30 days prior to start of planned conditioning through day +7 of HSCT at time of enrollment
- •Child planned to receive follow-up care after discharge for HSCT at study site
- •Child is <18 years at the time of enrollment
- •Parent/guardian screen positive for self-reported low-income (<200% FPL)
- •Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- •Provider approval for permission to approach
排除标准
- •Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- •Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
- •Foreign national family receiving care as an Embassy-pay patient
- •Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- •Child or household member receiving SSI
- •Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- •Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy
- •Foreign national family receiving care as an Embassy-pay patient
- •Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- •Child previously received RISE intervention
- •Child or household member receiving SSI
研究组 & 干预措施
PediRISE Program Group
Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:
- Baseline survey in-person, by telephone, or virtually.
- PediRISE program orientation with study team member, in-person or virtual.
- Optional meeting with certified benefits counselor.
- Receive fixed funds twice a month for 6 months.
- Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
- End of study survey.
干预措施: PediRISE Resource Program (Behavioral)
Usual Care Group
Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:
- Baseline survey in-person, by telephone, or virtually, and orientation with study team member.
- Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
- End of study survey.
结局指标
主要结局
Participant Consent Rate
时间窗: 1 Day
The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.
Participant Attrition Rate
时间窗: At 6 months
The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.
次要结局
未报告次要终点
研究者
Kira Bona, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute