Clinical trial NCT06464237: Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
Official title: Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Metacognition
Pediatric cancer
Neurorehabilitation
Cognitive training
Physical training
Adolescents with cancer
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2024-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: Junior Metacognitive Awareness Inventory
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up
Secondary outcomes:
measure: Wechsler Intelligence Scale For Children: 5th Ed (WISC-V)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: Color-Word Interference Test
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: Tower of Hanoi (D-KEFS)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: Verbal learning and memory test (VLMT)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: Pattern learning (Basic-MLT)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: German Motor Performance Test (DMT)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period.
measure: Behaviour Rating Inventory of Executive Function
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Other outcomes:
measure: Physical Self-Description Questionnaire (PSDQ-S)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
measure: Pediatric quality of life multidimensional fatigue scale (PedsQL-MFS)
timeFrame: At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Locations:
city: Bern
country: Switzerland
facility: Insespital, University Hospital Bern
Study officials:
affiliation: Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
name: Regula Everts, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: