Clinical trial · Interventional
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mio-App | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Training group
- description
- Training with Mio-App for 5 weeks, three times per week.
- interventionNames
- Behavioral: Mio-App
- type
- NO_INTERVENTION
- label
- Control group
- description
- Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment.
Primary outcomes (1)
- measure
- Junior Metacognitive Awareness Inventory
- timeFrame
- At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available