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NCT Number: NCT06464237

Metacognitive Intervention in Youth With Oncological Disease - the Mio 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.

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Key information

Conditions

Cancer Neoplasms

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insespital, University Hospital Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Regula Everts, Prof. Dr. phil.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mio-App

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Indices ranging from 0 to 155. Higher scores mean better outcome.

  2. Color-Word Interference Test

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.

  3. Tower of Hanoi (D-KEFS)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.

  4. Verbal learning and memory test (VLMT)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Percentile ranks ranging from 0-100. Higher scores mean better outcome.

  5. Pattern learning (Basic-MLT)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Percentile ranks ranging from 0-100. Higher scores mean better outcome.

  6. German Motor Performance Test (DMT)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period.

    Percentile ranks ranging from 0-100. Higher scores mean better outcome.

  7. 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.

    Percentile ranks ranging from 0-100. Higher scores mean better outcome.

Other outcomes

  1. Physical Self-Description Questionnaire (PSDQ-S)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

    Short version, Likert scale ranging from 1 to 6. Higher scores mean better outcome.

  2. Questionnaire for the Assessment of Resources and Competencies in Childhood and Adolescence (FRKJ)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

    Stanine rank from 1-9. Higher score mean better outcome.

  3. Pediatric quality of life multidimensional fatigue scale (PedsQL-MFS)

    Time frame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.

    5-point Likert scale ranging from 0 to 4. Higher scores mean better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Regula Everts, Prof. Dr. phil.

CONTACT

[email protected]

+41 31 632 84 97

Saskia Salzmann, MSc

CONTACT

[email protected]

+41 31 664 59 84

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Acronym: Mio

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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