Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test)
研究概览
简要总结
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.
详细描述
Aims and Hypotheses:
The overall purpose of this study is threefold: first, this study aims to deepen the knowledge about particular patterns of long-term cognitive impairment in pediatric cancer survivors. Understanding the nature of cognitive deficits in this population will be helpful for developing tailored therapeutic strategies. Second, the availability of well-designed child-friendly evidence-based training is of major clinical relevance to prevent school problems and further decline of cognitive functions. Third, the detection of training-induced neuronal changes in white-matter structure will give insight into the functional plasticity of the child's brain. In addition, training-induced changes in white matter would build strong evidence for the effect of the particular intervention.
The following hypotheses will be assessed in particular in the present study:
- Children with history of brain tumors (BT) show particular problems in memory and attention, resulting in a general deficit in several cognitive areas. Children with a history of cancer without involvement of the CNS show fewer problems than children with a history of cancer with BT in the same cognitive domains but more problems than healthy control children.
- Standardized working memory training leads to improvement of working memory performance. Transfer of the training effect especially to the areas of executive functions, memory and attention is expected.
- Physical training leads to improvement of coordination, endurance and motor strength. A transfer to several cognitive areas (i.e. executive functions) and physical self-concept is expected.
- After working memory training and physical training, the white matter structure of the patients will show significant changes in fractional anisotropy. There will also be changes in functional connectivity.
- Neuropsychological effects of training will still be present after 6 months post training for both experimental groups.
All comparisons will be carried out on an individual level (intra-individual level, primary objective) as well as on an inter-individual level (between-groups comparisons, secondary objective). The level of significance is set to α = 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Participant's individual score in executive functions (Subtest Block Recall; Color-Word Interference Test)
时间窗: 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).
次要结局
未报告次要终点