Cognitive Intervention After a Brain Tumor
研究概览
详细说明
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5S1W8
- Princess Margaret Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
- sufficient motor and sensory functioning to complete study activities
- availability to complete all study activities
- for patients treated with cranial radiation, at least 3 months post-radiation
Exclusion Criteria:
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Brain Training
8-session cognitive training program
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实验性的:Brain Health
8-session cognitive education program
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无干预:控制
候补名单控制组
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in cognitive composite score
大体时间:baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on neuropsychological tests
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in functional composite score
大体时间:baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of occupational functioning
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in quality of life composite score
大体时间:baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in caregiver quality of life composite score
大体时间:baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect and caregiver burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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合作者和调查者
调查人员
- 首席研究员:Kim Edelstein, PhD、Princess Margaret Cancer Centre, University Health Network
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Brain Training Program的临床试验
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中