跳至主要内容
临床试验/NCT03638453
NCT03638453已完成不适用

Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention

Dana-Farber Cancer Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Percentage of Participants Recruited

研究概览

简要总结

The goal of this new intervention is to make it easier for families to meet their basic household needs during childhood cancer treatment. The investigators want to learn how to best use PediCARE to help care for families.

详细描述

The investigators know from previous studies that in addition to the basic worries about a child's cancer therapy, many families experience financial stress during their child's treatment. Financial stress may include difficulty paying the rent or mortgage, keeping the electricity or heat on, or putting food on the table. One of the investigators' research goals is to find ways to decrease the financial impact of treatment on each family, and make sure that financial stress does not impact a child's experience during treatment.

The investigators have developed a new supportive care intervention called PediCARE (which stands for Pediatric Cancer Resource Equity) which provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through services such as Uber and Lyft). The investigators have evaluated the PediCARE support program in a small group of parents and used feedback from these parents to improve PediCARE. The investigators are now ready to do a feasibility study to find out whether the investigators can reliably deliver the PediCARE intervention to families.

This type of study is called a feasibility study. The goal of this research study is to learn whether the investigators can successfully give the PediCARE support program to families-in other words, whether most families are interested in participating in a randomized study about the PediCARE support program and whether they use the PediCARE support program during the study. The investigators will also begin to understand whether the PediCARE support program reduces financial stress for families during therapy. Long-term, the investigators plan to test the PediCARE support program in a larger group of randomized families to answer the question of whether PediCARE reduces financial stress for families and improves outcomes during cancer treatment

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
1 Day 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child newly diagnosed with cancer within 2 months;
  • Planned receipt of at least 4 cycles of chemotherapy at DFCI or UAB;
  • Parent/guardian screened positive for HMH*;
  • Child is <18 years at time of enrollment
  • In accordance with previous research1 families will be operationalized as having HMH for eligibility purposes if they report at least one of the below four concrete needs assessed during routine clinical care as follows:
  • Food insecurity.
  • Housing Insecurity.
  • Energy Insecurity.
  • Transportation Insecurity.
  • HMH screening is performed as standard of care by site-specific psychosocial providers.

排除标准

  • Child with diagnosis of relapsed cancer;
  • Child planned to receive fewer than 4 cycles of chemotherapy
  • Child planned to receive observation, radiation or surgical resection only;
  • Planned transfer of child to a non-DFCI or UAB facility for chemotherapy treatment;
  • Foreign national family receiving cancer care as an Embassy-pay patient;
  • Child is enrolled on DFCI 16-001 (due to ongoing embedded descriptive HMH study)

结局指标

主要结局

Percentage of Participants Recruited

时间窗: 6-months

At least 75 percent consent to randomization (e.g. recruitment).

Percentage of Attrition

时间窗: 6-months

At most 20 percent attrition per arm.

次要结局

  • Change in Household Material Hardship (HMH) in PediCARE vs Usual Care(6-months)
  • Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm(6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kira Bona, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

研究点 (2)

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