Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
NCT ID: NCT06464237
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-01
2027-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Training group
Training with Mio-App for 5 weeks, three times per week.
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.
Control group
Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
16 Years
ALL
Yes
Sponsors
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University of Bern
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Regula Everts, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
Locations
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Insespital, University Hospital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Related Links
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Other Identifiers
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BASEC2023-01196
Identifier Type: -
Identifier Source: org_study_id
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