Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors

NCT02749877 | Completed

• 1 other identifier: 196/15
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Pediatric Cancer; Training; Working Memory; Physical Activity; Brain Tumor; Physical Exercise

Outcome Measures

Primary Outcomes (1)

• Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test)

  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).

  baseline - 8 weeks - 3 months

Study Arms (3)

Cognitive Training

EXPERIMENTAL

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

Physical Training

EXPERIMENTAL

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

Waiting Control Group

ACTIVE COMPARATOR

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; Behavioral: Physical Training

Interventions

Working Memory Training BEHAVIORAL

(Training Details already described above)

Cognitive Training; Waiting Control Group

Physical Training BEHAVIORAL

(Training Details already described above)

Physical Training; Waiting Control Group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Children's Hospital

Bern, 3010, Switzerland

Location

Related Publications (2)

• Benzing V, Spitzhuttl J, Siegwart V, Schmid J, Grotzer M, Heinks T, Roebers CM, Steinlin M, Leibundgut K, Schmidt M, Everts R. Effects of Cognitive Training and Exergaming in Pediatric Cancer Survivors-A Randomized Clinical Trial. Med Sci Sports Exerc. 2020 Nov;52(11):2293-2302. doi: 10.1249/MSS.0000000000002386.

  PMID: 33064404 DERIVED

• Benzing V, Eggenberger N, Spitzhuttl J, Siegwart V, Pastore-Wapp M, Kiefer C, Slavova N, Grotzer M, Heinks T, Schmidt M, Conzelmann A, Steinlin M, Everts R, Leibundgut K. The Brainfit study: efficacy of cognitive training and exergaming in pediatric cancer survivors - a randomized controlled trial. BMC Cancer. 2018 Jan 3;18(1):18. doi: 10.1186/s12885-017-3933-x.

  PMID: 29298678 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity; Brain Neoplasms

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Behavior; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kurt Leibundgut, MD Prof

  Inselspital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 25, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CH (1)