Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 76
- 主要终点
- Change in financial distress
研究概览
简要总结
The overall goals of this study are to measure parents' financial distress (worry or anxiety about money) during their child's/adolescent's treatment for acute lymphoblastic leukemia and whether it changes over time, and to learn what factors are associated with changes in financial distress. Information gathered from this study will inform future intervention studies that may mitigate financial distress for parents of children/adolescents being treated for acute lymphoblastic leukemia.
详细描述
PRIMARY OBJECTIVE:
I. Determine the trajectory of financial distress over time, as reported by parents of children and adolescents ages 1 to 14.9 years with acute lymphoblastic leukemia (ALL), from start to completion of ALL therapy.
SECONDARY OBJECTIVE:
I. Identify factors associated with financial distress over time for families of children and adolescents ages 1 to 14.9 years with newly diagnosed ALL.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Children's Oncology Group (COG) NCI Community Oncology Research Program (National Cancer Institute [N]CORP) institutions are eligible for participation in this study upon first parent enrollment
- •Parents of an index child who meets the following characteristics are eligible for this study:
- •Index child must be newly diagnosed with de novo ALL
- •Index child must be between the ages of 1 and 14.9 years at the time of the parent's enrollment
- •At the parent's entry to the study, the index child must be receiving induction chemotherapy for newly diagnosed ALL at the enrolling institution. The index child may be enrolled in therapeutic clinical ALL trials or receiving ALL therapy per standard of care
- •Parents age 18 years and above are eligible for this study
- •Parent must speak English or Spanish in order to participate in the consent process and provide consent. The parent's language skills must be sufficient to understand the study requirements and complete the survey and interview questions
- •At the parent's entry to the study, the index child must be receiving induction chemotherapy for newly diagnosed ALL at the enrolling institution. The index child may be enrolled in therapeutic clinical ALL trials or receiving ALL therapy per standard of care
- •REGULATORY REQUIREMENTS: All parents must sign a written informed consent for their participation in the study
- •REGULATORY REQUIREMENTS: All institutional and NCI requirements for human studies must be met
排除标准
- •Parents of index children with any of the following clinical characteristics will be excluded from the study:
- •KMT2A-R (formerly MLL-R) not receiving ALL therapy
- •Mixed-phenotype acute leukemia (MPAL) not receiving ALL therapy
- •Burkitt's leukemia
结局指标
主要结局
Change in financial distress
时间窗: From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Financial distress will be measured serially using the Personal Finance Wellbeing (PFW) scale (previously InCharge Financial Distress/Financial Well-Being scale). Scores on the PFW scale will be computed by adding numerical responses for each of the 8 questions, then dividing the total by 8. These scores can range from 1 to 10, with 1 indicating overwhelming financial distress and 10 indicating no financial distress.
次要结局
- Factors associated with financial distress(From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years)