Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Cancer Clinical Trial

— Mio  

Official title:

Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464237
• Other study ID #: BASEC2023-01196
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Regula Everts, Prof. Dr. phil.
• Phone: +41 31 632 84 97
• Email: regula.everts[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Mio-App
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.

Locations

Country	Name	City	State
Switzerland	Insespital, University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Link to Mio-Study