Metacognitive Intervention in Youth With Oncological Disease - the Mio Study
NCT Number: NCT06464237
Acronym: Mio
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Mio-App
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: University of Bern
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-11-01
Completion Date: 2026-04-01
Locations: Insespital, University Hospital Bern, Bern, 3014, Switzerland

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.

Primary Outcome Measures: Junior Metacognitive Awareness Inventory, Change from baseline in Junior Metacognitive Awareness Inventory to 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 Outcome Measures: Wechsler Intelligence Scale For Children: 5th Ed (WISC-V), Indices ranging from 0 to 155. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|Color-Word Interference Test, Scaled Scores ranging from 1 to 19. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|Tower of Hanoi (D-KEFS), Scaled Scores ranging from 1 to 19. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|Verbal learning and memory test (VLMT), Percentile ranks ranging from 0-100. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|Pattern learning (Basic-MLT), Percentile ranks ranging from 0-100. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|German Motor Performance Test (DMT), Percentile ranks ranging from 0-100. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period.|Behaviour Rating Inventory of Executive Function, Percentile ranks ranging from 0-100. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.
Other Outcome Measures: Physical Self-Description Questionnaire (PSDQ-S), Short version, Likert scale ranging from 1 to 6. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.|Strengths and Difficulties Questionnaire (SDQ), The total value is between 0 -40. Lower scores mean better outcome., 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), 5-point Likert scale ranging from 0 to 4. Higher scores mean better outcome., At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.