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Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02749877
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
Cancer survival comes at a price: pediatric cancer survivors have a high risk for a wide range of cognitive difficulties, particularly survivors of cancer involving the central nervous system (CNS, e.g., brain tumors [BT]) are prone to neurocognitive impairments in areas such as executive functions, working memory, attention, memory, visuospatial and motor skills, processing speed as well as language. The aim of this interdisciplinary longitudinal study is to extend empirical knowledge on training and transfer effects in children with a history of cancer. It is hypothesized that early cognitive and physical interventions affect the remediation of pediatric cancer survivors in terms of cognitive functions. These changes are further hypothesized to be associated with white matter changes.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Behavioral: Working Memory Training Behavioral: Physical Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors
Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Training
This group will undergo a working memory training program (Training A). The children will receive individual memory training based on the computer program Cogmed RM and will be supervised by trained neuropsychologists. Its efficacy in the use with children with cancer has been recently published. The children will undergo 25 training sessions "online"; each session takes about 45 minutes and consists of a selection of various tasks that target the different aspects of working memory.
Behavioral: Working Memory Training
(Training Details already described above)

Experimental: Physical Training
This group will receive a physical training that can be executed at home (Training B). The training will be based on xbox Kinect games and comprise games and activities such as jump'n'run games, physical training, and dance activities. One training session will last approximately 45 minutes and will be performed 3 days a week over a period of 8 weeks (in total 25 sessions).
Behavioral: Physical Training
(Training Details already described above)

Active Comparator: Waiting Control Group
This group will serve as a waiting control group and will receive either the physical or the working memory training program after completion of the Neuropsychological Assessment II
Behavioral: Working Memory Training
(Training Details already described above)

Behavioral: Physical Training
(Training Details already described above)




Primary Outcome Measures :
  1. Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test) [ Time Frame: baseline - 8 weeks - 3 months ]
    The primary endpoint in this study will be the participant's scores in executive functions based on the model of Miyake et al. (2000) which will be assessed using two different subtests: The subtest Block Recall from the Working Memory Test Battery for Children, WMTB-C (Pickering & Gathercole, 2001) and the Color-Word Interference Test from the Delis-Kaplan Executive Function System™ (D-KEFS™, (Delis, Kaplan, & Kramer, 2001).These tests will be administered at each neuropsychological testing, specifically, before and after the training intervention. It is expected to find a statistically significant amelioration in performance after the intervention (effect size f = 0.14 at a level of significance of α =0.05).



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749877


Locations
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Switzerland
University Children's Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Kurt Leibundgut, MD Prof Inselspital Bern, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02749877    
Other Study ID Numbers: 196/15
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital Inselspital, Berne:
Pediatric Cancer
Training
Working Memory
Physical Activity
Brain Tumor
Physical Exercise