NCT06464237 Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
| NCT ID | NCT06464237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Regula Everts, Prof. Dr.
PRINCIPAL INVESTIGATOR
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
Frequently Asked Questions
Who can join the NCT06464237 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06464237 currently recruiting?
Yes, NCT06464237 is actively recruiting participants. Contact the research team at regula.everts@insel.ch for enrollment information.
Where is the NCT06464237 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06464237 clinical trial?
NCT06464237 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Regula Everts, Prof. Dr. at Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland. The trial plans to enroll 40 participants.
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