Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

NCT06464237 | Recruiting

• 1 other identifier: BASEC2023-01196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Metacognition; Pediatric cancer; Neurorehabilitation; Cognitive training; Physical training; Adolescents with cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

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

• Color-Word Interference Test

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

• Tower of Hanoi (D-KEFS)

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

• Verbal learning and memory test (VLMT)

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

• Pattern learning (Basic-MLT)

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

Other Outcomes (3)

• Physical Self-Description Questionnaire (PSDQ-S)

  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)

  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)

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

Study Arms (2)

Training group

ACTIVE COMPARATOR

Training with Mio-App for 5 weeks, three times per week.

Behavioral: Mio-App

Control group

NO INTERVENTION

Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment.

Interventions

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.

Also known as: Mio-Training

Training group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Insespital, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Links

• Link to Mio-Study

MeSH Terms

Conditions

Neoplasms

Study Officials

• Regula Everts, Prof. Dr.

  Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regula Everts, Prof. Dr. phil.

CONTACT

+41 31 632 84 97; regula.everts@insel.ch

Saskia Salzmann, MSc

CONTACT

+41 31 664 59 84; saskia.salzmann@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)