NCT02300961已完成不适用
A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of participants who complete the post-transplant neurocognitive intervention program
研究概览
简要总结
This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.
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
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy.
- •Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed.
- •Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent.
排除标准
- •Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents.
- •Pregnant patients will be excluded.
研究组 & 干预措施
Cognitive rehabilitation arm
Experimental
Cognitive rehabilitation program
干预措施: Cognitive rehabilitation program (Behavioral)
结局指标
主要结局
Number of participants who complete the post-transplant neurocognitive intervention program
时间窗: 3 months after enrollment
Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment.
次要结局
- Change in WISC-IV or WAIS-IV scores(Baseline, 1 year post-treatment, 2 years post-treatment)
- Change in WRAML-2 scores(Baseline, 1 year post-treatment, 2 years post-treatment)
- Number of participants who complete at least half of the neurocognitive intervention program(3 months after enrollment)
- Change in executive functioning scores (D-KEFS or NEPSY-II)(Baseline, 1 year post-treatment, 2 years post-treatment)
- Change in CPT-II scores(Baseline, 1 year post-treatment, 2 years post-treatment)
研究者
研究点 (2)
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