Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (Mio)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Mio-App

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Regula Everts, Prof. Dr. phil.; Phone Number: +41 31 632 84 97; Email: regula.everts@insel.ch
• Study Contact Backup: Name: Saskia Salzmann, MSc; Phone Number: +41 31 664 59 84; Email: saskia.salzmann@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Insespital, University Hospital Bern
    • Principal Investigator: Regula Everts, Prof. Dr. phil.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training group; Training with Mio-App for 5 weeks, three times per week.	Behavioral: 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 Names: Mio-Training
No Intervention: Control group; Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)	Indices ranging from 0 to 155. Higher scores mean better outcome.	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.	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.	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.	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.	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.	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.	At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Self-Description Questionnaire (PSDQ-S)	Short version, Likert scale ranging from 1 to 6. Higher scores mean better outcome.	At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Pediatric quality of life multidimensional fatigue scale (PedsQL-MFS)	5-point Likert scale ranging from 0 to 4. Higher scores mean better outcome.	At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Questionnaire for the Assessment of Resources and Competencies in Childhood and Adolescence (FRKJ)	Stanine rank from 1-9. Higher score mean better outcome.	At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Bern
• Investigators: Principal Investigator: Regula Everts, Prof. Dr., Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

Publications and helpful links

Helpful Links

• Link to Mio-Study

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Metacognition; Neurorehabilitation; Cognitive training; Pediatric cancer; Physical training; Adolescents with cancer
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BASEC2023-01196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No