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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 January 2017
Main ID:  NCT02749877
Date of registration: 12/04/2016
Prospective Registration: Yes
Primary sponsor: University Hospital Inselspital, Berne
Public title: Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors
Scientific title: Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors
Date of first enrolment: January 2017
Target sample size: 190
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02749877
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name:   Kurt Leibundgut, Prof. Dr.
Address: 
Telephone: +41 31 632 9337
Email: kurt.leibundgut@insel.ch
Affiliation: 
Name:   Kurt Leibundgut, MD, Prof
Address: 
Telephone: 0041 (0)31 632 94 95
Email: kurt.leibundgut@insel.ch
Affiliation: 
Name:   Kurt Leibundgut, MD Prof
Address: 
Telephone:
Email:
Affiliation:  Inselspital Bern, Switzerland
Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent as documented by signature of participants and / or parents / legal
guardians

- Age 7-16 years

- A history of cancer either with or without CNS involvement in the past 10 years and
termination of treatment at least 12 months prior to participation in the study

- Treatment of cancer including either radiation and / or chemotherapy in addition to
surgical tumor removal if the cancer did not involve the CNS

Exclusion Criteria:

- Contraindication to cognitive training and / or presentation of physical activity on
a TV- or computer screen, in particular epilepsy

- Any other instable neurological or physical condition

- Cancer treatment of only surgical intervention without subsequent radiation and / or
chemotherapy if the CNS was not affected

- For female participants: Pregnancy or breast feeding; or, intention to become
pregnant during the course of the experiment; or, lack of safe contraception (defined
as: female participants of childbearing potential, not using a medically reliable
method of contraception, such as oral, injectable, or implantable contraceptives, or
intrauterine contraceptive devices, or who are not using any other method considered
sufficiently reliable by the investigator in individual cases). A pregnancy test will
be provided for participants of ages 14 and older

- Known or suspected non-compliance, drug or alcohol abuse

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, etc. of the participant

- Enrolment of the investigator, his/her family members, employees and other dependent
persons



Age minimum: 7 Years
Age maximum: 16 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pediatric Cancer
Intervention(s)
Behavioral: Physical Training
Behavioral: Working Memory Training
Primary Outcome(s)
Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test) [Time Frame: baseline - 8 weeks - 3 months]
Secondary Outcome(s)
Secondary ID(s)
196/15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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