Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Bern | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training group | Active Comparator | Training with Mio-App for 5 weeks, three times per week. |
|
| Control group | No Intervention | Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mio-App | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Junior Metacognitive Awareness Inventory | 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. | At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Intelligence Scale For Children: 5th Ed (WISC-V) | Indices ranging from 0 to 155. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period. |
| Color-Word Interference Test |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Self-Description Questionnaire (PSDQ-S) | Short version, Likert scale ranging from 1 to 6. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up. |
| Questionnaire for the Assessment of Resources and Competencies in Childhood and Adolescence (FRKJ) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regula Everts, Prof. Dr. phil. | Contact | +41 31 632 84 97 | regula.everts@insel.ch | |
| Saskia Salzmann, MSc | Contact | +41 31 664 59 84 | saskia.salzmann@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Regula Everts, Prof. Dr. | Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insespital, University Hospital Bern | Recruiting | Bern | 3010 | Switzerland |
Not provided
| Label | URL |
|---|---|
| Link to Mio-Study | View source |
Not provided
Data can be shared upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.
| At baseline; immediately (up to 1 week) after the training or waiting period. |
| Tower of Hanoi (D-KEFS) | Scaled Scores ranging from 1 to 19. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period. |
| Verbal learning and memory test (VLMT) | Percentile ranks ranging from 0-100. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period. |
| Pattern learning (Basic-MLT) | Percentile ranks ranging from 0-100. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period. |
| German Motor Performance Test (DMT) | Percentile ranks ranging from 0-100. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period. |
| Behaviour Rating Inventory of Executive Function | Percentile ranks ranging from 0-100. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up. |
Stanine rank from 1-9. Higher score mean better outcome. |
| At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up. |
| Pediatric quality of life multidimensional fatigue scale (PedsQL-MFS) | 5-point Likert scale ranging from 0 to 4. Higher scores mean better outcome. | At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up. |