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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02749877 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors
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Scientific title:
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Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02749877 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Kurt Leibundgut, MD Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inselspital Bern, Switzerland |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Pediatric Cancer
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Intervention(s)
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Behavioral: Working Memory Training
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Behavioral: Physical Training
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Primary Outcome(s)
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Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test)
[Time Frame: baseline - 8 weeks - 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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