NCT06464237Recruiting
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
Summary
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Insel Gruppe AG, University Hospital Bern(Other)
- Protocol no.
- BASEC2023-01196
- Conditions
- Cancer
- Interventions
- Behavioral
Treatments studied
- Mio-App
Collaborators
University of Bern
Locations · 1
- Bern, SwitzerlandInsespital, University Hospital BernRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: November 26, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.