My Study
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Unstable neurological condition Severe psychiatric diagnosis or severe learning disability Substance or alcohol abuse (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
University Hospital Bern, Inselspital (Regula Everts)
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof.Dr.phil. Regula Everts
+41 31 664 59 84
regula.everts@clutterinsel.chChildrens University Hospital Bern, Inselspital
(BASEC)
Allgemeine Auskünfte
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)
Allgemeine Auskünfte
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)
Wissenschaftliche Auskünfte
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)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.08.2023
(BASEC)
ICTRP Studien-ID
NCT06464237 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Metacognitive Intervention in youth with Oncological disease - Mio Study (BASEC)
Wissenschaftlicher Titel
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Öffentlicher Titel
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Untersuchte Krankheit(en)
Cancer (ICTRP)
Untersuchte Intervention
Other: Mio-App (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
BASEC2023-01196 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06464237 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar