My Study
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
Unstable neurological condition Severe psychiatric diagnosis or severe learning disability Substance or alcohol abuse (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
University Hospital Bern, Inselspital (Regula Everts)
(BASEC)
Contact
Contact Person Switzerland
Prof.Dr.phil. Regula Everts
+41 31 664 59 84
regula.everts@clutterinsel.chChildrens University Hospital Bern, Inselspital
(BASEC)
General Information
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)
General Information
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)
Scientific Information
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 of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
31.08.2023
(BASEC)
ICTRP Trial ID
NCT06464237 (ICTRP)
Official title (approved by ethics committee)
Metacognitive Intervention in youth with Oncological disease - Mio Study (BASEC)
Academic title
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Public title
Metacognitive Intervention in Youth With Oncological Disease - the Mio Study (ICTRP)
Disease under investigation
Cancer (ICTRP)
Intervention under investigation
Other: Mio-App (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Bern (ICTRP)
Additional contacts
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)
Secondary trial IDs
BASEC2023-01196 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06464237 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available