Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Participation Rate
研究概览
简要总结
The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:
- Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects?
- Will cognitive training via virtual reality provide neurocognitive benefits?
- Will there be predictable changes in brain activity as measured by neuroimaging?
Findings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.
详细描述
The objectives of this study are:
Primary Objective:
• To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.
Secondary Objectives:
- To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad.
- To evaluate patterns of cortical activation (oxygenated and deoxygenated hemoglobin responses) pre- and post- cognitive training in the virtual reality setting and on an iPad.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single Blind
入排标准
- 年龄范围
- 8 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initiating radiotherapy for a BT
- •Between 8-22 years of age at the time of enrollment
- •English or Spanish as the primary language
- •Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
- •Participant willing to take part in required aspects of Cogmed training
排除标准
- •Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology [NOPP])
- •History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness
- •Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)
- •Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)
- •Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation/planning but not daily treatment)
研究组 & 干预措施
IPad Cogmed Training
The investigator will be randomizing participants to complete Cogmed training on an iPad.
干预措施: Cognitive training via iPad (Other)
Virtual Reality Cogmed Training
The investigator will be randomizing participants to complete Cogmed training in Virtual Reality.
干预措施: Cognitive training via virtual reality (Other)
结局指标
主要结局
Participation Rate
时间窗: After approach for enrollment, an average of 3 weeks after starting radiation therapy
The participation rate of this study (i.e., how many patients agree to participate/how many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants.
Adherence
时间窗: At the completion of radiation therapy, an average of 6 weeks after enrollment
The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups.
Side Effects
时间窗: At the completion of radiation therapy, an average of 6 weeks after enrollment
Summary statistics, including counts and percentages of side effects/cyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality.
次要结局
- Cerebral Hemodynamics(After completion of post-training assessment, an average of 8 weeks after enrollment)
- Neurobehavioral(After completion of post-training assessment, an average of 8 weeks after enrollment)