My Study
Résumé de l'étude
Therefore, we have developed an app (Mio Program) specifically designed for adolescents with cancer. In this study, we want to investigate whether the Mio Program helps to strengthen cognitive and physical development in adolescents with cancer. Adolescents aged 8-16 years with cancer can participate in the study if the patient meets the inclusion criteria.
(BASEC)
Intervention étudiée
The goal of the Mio Program is to provide strategies through targeted cognitive and physical exercises to strengthen the adolescents' metacognition and thereby facilitate their reintegration into school and daily life.
(BASEC)
Maladie en cours d'investigation
Despite improved medical care for adolescents with cancer, many adolescents show cognitive and physical long-term consequences due to cancer or the chosen therapy. These long-term consequences can lead to difficulties in school, limitations in daily life in general, and also to a reduced quality of life.
(BASEC)
Age between 8-16 years Diagnosis of cancer Treatment of cancer with radiation, chemotherapy, or surgical intervention (BASEC)
Critères d'exclusion
Unstable neurological condition Severe psychiatric diagnosis or severe learning disability Substance or alcohol abuse (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
University Hospital Bern, Inselspital (Regula Everts)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof.Dr.phil. Regula Everts
+41 31 664 59 84
regula.everts@clutterinsel.chChildrens University Hospital Bern, Inselspital
(BASEC)
Informations générales
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland,
+41 31 632 84 97
regula.everts@clutterinsel.ch(ICTRP)
Informations générales
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
+41 31 632 84 97
regula.everts@clutterinsel.ch(ICTRP)
Informations scientifiques
Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland,
+41 31 632 84 97
regula.everts@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
31.08.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06464237 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Metacognitive Intervention in youth with Oncological disease - Mio Study (BASEC)
Titre académique
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Titre public
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Maladie en cours d'investigation
Cancer (ICTRP)
Intervention étudiée
Other: Mio-App (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Junior Metacognitive Awareness Inventory (ICTRP)
Wechsler Intelligence Scale For Children: 5th Ed (WISC-V);Color-Word Interference Test;Tower of Hanoi (D-KEFS);Verbal learning and memory test (VLMT);Pattern learning (Basic-MLT);German Motor Performance Test (DMT);Behaviour Rating Inventory of Executive Function (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Bern (ICTRP)
Contacts supplémentaires
Regula Everts, Prof. Dr.;Regula Everts, Prof. Dr. phil., regula.everts@insel.ch, +41 31 632 84 97, Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland, (ICTRP)
ID secondaires
BASEC2023-01196 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06464237 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible