CancerMioNCT06464237
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
A study testing Mio-App in people with Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Mio-App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Insespital, University Hospital Bern
Bern, 3010
Regula Everts, Prof. Dr. phil.
About this study
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Mio-App
- Keywords
- Metacognition, Pediatric cancer, Neurorehabilitation, Cognitive training, Physical training, Adolescents with cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mio-AppBehavioural
Also called Mio-Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | Training with Mio-App for 5 weeks, three times per week. Receives: Behavioral: Mio-App |
| Control group | No intervention | Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
Secondary outcomes (7)
Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)
Indices ranging from 0 to 155. Higher scores mean better outcome.
Measured: At baseline; immediately (up to 1 week) after the training or waiting period.
Color-Word Interference Test
Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Aug 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Regula Everts, Prof. Dr., Principal investigator, Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464237
- Sponsor's protocol ID
- BASEC2023-01196
- Acronym
- Mio
- Status last verified
- Nov 2025
- First submitted
- 12 Jun 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared upon reasonable request
Publications
Salzmann S, Benzing V, Grunt S, Furtwangler R, Everts R. A Metacognitive Intervention for Children and Adolescents in Neuropediatric Care (Mio-Training): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 26;15:e95139. doi: 10.2196/95139.
PubMed 42361358
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
- ClinicalTrials.gov ID
- NCT06464237
- Acronym / sponsor ID
- Mio / BASEC2023-01196
- Conditions
- Cancer
- Keywords
- Metacognition, Pediatric cancer, Neurorehabilitation, Cognitive training, Physical training, Adolescents with cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Behavioral: Mio-AppTraining 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mio-AppAlso: Mio-TrainingThe 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. | Behavioural | Training group |
Primary outcome
Junior Metacognitive Awareness Inventory
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
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.
7 secondary outcomes
Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
Color-Word Interference Test
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
Tower of Hanoi (D-KEFS)
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
Verbal learning and memory test (VLMT)
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
Pattern learning (Basic-MLT)
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
German Motor Performance Test (DMT)
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.
Behaviour Rating Inventory of Executive Function
Time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 42361358Salzmann S, Benzing V, Grunt S, Furtwangler R, Everts R. A Metacognitive Intervention for Children and Adolescents in Neuropediatric Care (Mio-Training): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 26;15:e95139. doi: 10.2196/95139.
- Link to Mio-StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data can be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regula Everts, Prof. Dr. principal investigator
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mio-App in people with Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regula Everts, Prof. Dr. phil. (+41 31 632 84 97, regula.everts@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Junior Metacognitive Awareness Inventory (time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.