Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Junior Metacognitive Awareness Inventory
研究概览
简要总结
The aim of the Mio-Study is to address the current lack of effective treatment options to reduce cognitive and physical long-term problems in children and adolescents with cancer. Through the use of the Mio-App, cognitive and physical development will be strengthened and metacognitive thinking and awareness will increase.
The Mio-App for children and adolescence with cancer will include a combination of cognitive and physical training tasks and prospective as well as retrospective metacognitive questions. In a randomized controlled trial, the App will be analysed for its efficacy on metacognitive thinking and executive functions. In particular, the investigators are interested in factors that affect the efficacy of the training program such as compliance, age, sex or the presence of fatigue. This study will give insight into the role of metacognition in cognitive and physical performance and will foster the development of children and adolescents with cancer in the long-term.
详细描述
In the Mio-Study, the investigators are developing a training app at the interface between neuropsychology and sports science - the Mio-training. The aim of the Mio-training is to strengthen the cognitive and motor development of children and adolescents after cancer in the long-term. The App contains a combination of cognitive and physical training tasks and metacognitive questions to promote knowledge and awareness of one's own thinking. In order to counteract the shortage of skilled workers and the increasing specialization of individual specialist areas, solutions are needed that can be implemented without a lot of staff. From today's perspective, there are hardly any trainings for children and adolescents that show long-term effects on cognitive and motor development and can also be transferred to non-trained tasks in school and everyday life.
The investigators are testing the effectiveness of the Mio-training in a randomized clinical trial (RCT) and expect a strengthening of metacognition and core cognitive functions (i.e. executive functions). The Mio-Study will provide information about the role of metacognition in cognitive and physical performance and, ideally, provide evidence for a novel, interdisciplinary rehabilitation strategy for children and adolescents after cancer.
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent as documented by signature (see Informed Consent Form) of participants and / or parents / legal guardians
- •Age 8-16 years
- •A diagnosis of cancer either with or without CNS involvement. The participant will be included between 3 months before to 10 years after termination of treatment.
- •Treatment of cancer including either radiation, chemotherapy and/ or surgical tumor removal
- •German or French speaking
排除标准
- •Any other instable neurological condition (e.g. epilepsy)
- •A severe psychiatric disease (e.g., eating disorder) or severe learning disability
- •Known or suspected non-compliance
- •Drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Junior Metacognitive Awareness Inventory
时间窗: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
Total score of the Junior Metacognitive Awareness Inventory over the three timepoints (baseline, immediate followup \& 3-months follow-up). Raw values ranging 18-90. Higher scores mean better outcome.
Junior Metacognitive Awareness Inventory
时间窗: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
Total score of the Junior Metacognitive Awareness Inventory over the three timepoints (baseline, immediate followup \& 3-months follow-up). Raw values ranging 18-90. Higher scores mean better outcome.
次要结局
- Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)(At baseline; immediately (up to 1 week) after the training or waiting period.)
- Tower of Hanoi (D-KEFS)(At baseline; immediately (up to 1 week) after the training or waiting period.)
- Pattern learning (Basic-MLT)(At baseline; immediately (up to 1 week) after the training or waiting period.)
- German Motor Performance Test (DMT)(At baseline; immediately (up to 1 week) after the training or waiting period.)
- Color-Word Interference Test(At baseline; immediately (up to 1 week) after the training or waiting period.)
- Verbal learning and memory test (VLMT)(At baseline; immediately (up to 1 week) after the training or waiting period.)
- Behaviour Rating Inventory of Executive Function(At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.)