Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Cancer

Treatments

Behavioral: Mio-App

Study type

Interventional

Funder types

Other

Identifiers

NCT06464237

BASEC2023-01196

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

Accepts Healthy Volunteers

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