Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Trial Title: Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

NCT ID: NCT06464237

Condition: Cancer

Conditions: Keywords:
Metacognition
Pediatric cancer
Neurorehabilitation
Cognitive training
Physical training
Adolescents with cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Mio-App
Description: 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.
Arm group label: Training group

Other name: Mio-Training

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 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 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 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 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 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 adolescents after cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Informed consent as documented by signature (see Informed Consent Form) of participants and / or parents / legal guardians - Age 10-16 years - A diagnosis of cancer either with or without central nervous system (CNS) involvement - Treatment of cancer including either radiation, chemotherapy and/ or surgical tumor removal - Three months before to three months after the end of cancer treatment - 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

Gender: All

Minimum age: 10 Years

Maximum age: 16 Years

Healthy volunteers: No

Locations:

Facility:
Name: Insespital, University Hospital Bern

Address:
City: Bern
Zip: 3014
Country: Switzerland

Investigator:
Last name: Regula Everts, Prof. Dr. phil.
Email: Principal Investigator

Start date: November 1, 2024

Completion date: April 1, 2026

Lead sponsor:
Agency: Insel Gruppe AG, University Hospital Bern
Agency class: Other

Collaborator:
Agency: University of Bern
Agency class: Other

Source: Insel Gruppe AG, University Hospital Bern

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06464237
https://kinderklinik.insel.ch/de/lehre-und-forschung/forschung/forschung-nach-fachgebiet/neuropaediatrie/research-projects/mio-studie