Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mio-App
  The Mio-App aims to increase metacognitive knowledge, teaches mnemonic skills, trains the working memory capacity and motor skills to reduce cognitive and physical long-term sequelae after cancer during adolescence.

Первичные конечные точки

• Junior Metacognitive Awareness Inventory [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up]

Вторичные конечные точки (7)

• Wechsler Intelligence Scale For Children: 5th Ed (WISC-V) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Color-Word Interference Test [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Tower of Hanoi (D-KEFS) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Verbal learning and memory test (VLMT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Pattern learning (Basic-MLT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• German Motor Performance Test (DMT) [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period.]
• Behaviour Rating Inventory of Executive Function [Срок оценки: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Insespital, University Hospital Bern — Bern

Идентификаторы

NCT: NCT06464237 · BASEC2023-01196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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