My Study
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Unstable neurological condition Severe psychiatric diagnosis or severe learning disability Substance or alcohol abuse (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
University Hospital Bern, Inselspital (Regula Everts)
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof.Dr.phil. Regula Everts
+41 31 664 59 84
regula.everts@clutterinsel.chChildrens University Hospital Bern, Inselspital
(BASEC)
Informazioni generali
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)
Informazioni generali
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)
Informazioni scientifiche
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)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
31.08.2023
(BASEC)
ID di studio ICTRP
NCT06464237 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Metacognitive Intervention in youth with Oncological disease - Mio Study (BASEC)
Titolo accademico
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Titolo pubblico
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Malattie studiate
Cancer (ICTRP)
Intervento studiato
Other: Mio-App (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Bern (ICTRP)
Contatti aggiuntivi
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 secondari
BASEC2023-01196 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06464237 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile