Metacognitive Intervention in Youth With Oncological Disease - the Mio Study

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

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NCT-Nummer:
NCT06464237

Studienbeginn:
November 2024

Letztes Update:
21.06.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Insel Gruppe AG, University Hospital Bern

Collaborator:
University of Bern

Studienleiter

Regula Everts, Prof. Dr.
Principal Investigator
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

Kontakt

Regula Everts, Prof. Dr. phil.
Kontakt:
Phone: +41 31 632 84 97
E-Mail: regula.everts@insel.ch» Kontaktdaten anzeigen

Saskia Salzmann, MSc
Kontakt:
E-Mail: saskiadebora.salzmann@extern.insel.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Insespital, University Hospital Bern
3014 Bern
Switzerland» Google-Maps

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Junior Metacognitive Awareness Inventory (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up):
Change from baseline in Junior Metacognitive Awareness Inventory to 3-months follow-up. Raw values ranging 18-90. Higher scores mean better outcome.

Secondary outcome:

1. Wechsler Intelligence Scale For Children: 5th Ed (WISC-V) (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Indices ranging from 0 to 155. Higher scores mean better outcome.

2. Color-Word Interference Test (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.

3. Tower of Hanoi (D-KEFS) (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Scaled Scores ranging from 1 to 19. Higher scores mean better outcome.

4. Verbal learning and memory test (VLMT) (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Percentile ranks ranging from 0-100. Higher scores mean better outcome.

5. Pattern learning (Basic-MLT) (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Percentile ranks ranging from 0-100. Higher scores mean better outcome.

6. German Motor Performance Test (DMT) (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period.):
Percentile ranks ranging from 0-100. Higher scores mean better outcome.

7. Behaviour Rating Inventory of Executive Function (Time Frame - At baseline; immediately (up to 1 week) after the training or waiting period; at 3-months follow-up.):
Percentile ranks ranging from 0-100. Higher scores mean better outcome.

Studien-Arme

Active Comparator: Training group
Training with Mio-App for 5 weeks, three times per week.
No Intervention: Control group
Waiting control group. Participants may use the Mio-App after completion of the last follow-up assessment.

Geprüfte Regime

Mio-App (Mio-Training):
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.

Quelle: ClinicalTrials.gov

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