Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Feasibility - Enrollment
研究概览
简要总结
The goal of this study is to learn if an online computerized training program improves processing speed, attention, and working memory in children with a primary brain tumor during and after active cancer treatment. The main questions it aims to answer are:
- Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?,
- Is the cognitive intervention acceptable to children and caregivers?, and
- Does the cognitive intervention improve neuropsychological functioning?
There is no comparison group for this study.
Participants will:
- Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks;
- Have weekly check-ins with the cognitive coach,
- Complete a survey at the end of the cognitive training program, and
- Complete pre- and post- neuropsychological testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a primary brain tumor,
- •Children and young adults 5 to 25 years of age at the time of enrollment,
- •Within five years of initial brain tumor diagnosis,
- •Receiving care through the Johns Hopkins neuro-oncology program.
排除标准
- •Significant visual, hearing, motor, or cognitive impairment that precludes participation in computerized cognitive training program;
- •Acute medical status (e.g., significant risk for mortality within 3-months of diagnosis).
研究组 & 干预措施
Cognitive Intervention
Computerized cognitive training program focused on processing speed.
干预措施: Online computerized cognitive training intervention focused on processing speed. (Behavioral)
结局指标
主要结局
Feasibility - Enrollment
时间窗: Up to 5 years after diagnosis.
Study enrollment rate.
Feasibility - Participant Retention
时间窗: 8 weeks
Number of participants who complete the computerized brain training program.
Feasibility - Intervention Adherence
时间窗: Through study completion, an average of 8 weeks.
Number of levels completed in the cognitive training program. Qualitative feedback regarding barriers and facilitators to engagement will also we collected to provide descriptive context.
Feasibility - Total Intervention Time
时间窗: 8 weeks
Total time spent completing the cognitive training program exercises.
Acceptability
时间窗: At the end of the 8-week intervention.
Parent and self-reported acceptability measured using a Likert-scale questionnaire administered at the end of the intervention. Mean total score will be reported. Qualitative feedback regarding participant experience will also be collected to provide descriptive context.
次要结局
- Cognitive Training Task-Based Performance(Prior to the intervention, immediately following intervention, and 6 months after intervention completion.)
- Processing Speed(Prior to the intervention, immediately following intervention, and 6 months after intervention completion.)
- Attention(Prior to the intervention, immediately following intervention, and 6 months after intervention completion.)
- Working Memory(Prior to the intervention, immediately following intervention, and 6 months after intervention completion.)