Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Examination of the quantitative training program progression data
研究概览
简要总结
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory and cognitive functioning in patients suffering from "chemobrain".
详细描述
Breast cancer is the most common malignancy in women in the United States, with an estimated 211,240 new cases of invasive breast cancer diagnosed among women, and 1,700 diagnosed in men, in 2005. While cure rates have improved significantly, chemotherapy for breast cancer is associated with a number of negative side effects. One of which is a deficit in cognitive function, a condition commonly referred to as "chemobrain". While the debate about cognitive decline being a result of chemotherapy is still ongoing, there is clear evidence of cognitive decline in women with breast cancer post-chemotherapy. Cognitive decline is often reported to affect memory, attention, executive functioning and information processing speed.
Studies suggest that incidence of "chemobrain" ranges from 17% - 75% in women who have undergone chemotherapy.This cognitive impairment affects quality of life by impacting patients' ability to concentrate, make decisions and to fulfill family, career, and community responsibilities.
Although there is uncertainty about the mechanisms that can lead to this cognitive decline, there is a pressing need to identify interventions that will alleviate its symptoms and help breast cancer survivors recover their cognitive functioning and resume their roles and activities at the pre-cancer level.
Brain plasticity refers to the brain's capacity for physical and functional change; it is this capacity that explains how experience induces learning throughout life. On the basis of a growing body of literature in the fields of psychophysics, neurology, neuropsychology, and brain plasticity, we hypothesize that the brain processing machinery can be refined, elaborated, and strengthened through rigorous training and learning. The purpose of this study is to investigate if such training can improve cognitive functioning.
We hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance will help improve memory and cognitive functioning in patients suffering from "chemobrain".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older at the time of consent.
- •Diagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents in the past 5 years.
- •Cognitive decline, as reported by the patient, friends, or family.
- •Fluent English speaker.
- •Willing and able to commit to the 6-month time requirement of the entire study period.
- •Willing to provide informed consent
- •Willing to participate in training of the program.
- •Agrees to weekly contact
排除标准
- •Severe hearing impairments that would:
- •limit the ability to receive instructions and support; and
- •hinder performance on the computer training program.
- •Self-report of untreated Axis I or II disorders (with the exception of depression, anxiety disorders, and panic disorders).
- •Self-report of current diagnosis or history of major neurological illness including, but not limited to:
- •Alzheimer's disease
- •Parkinson's disease
- •Multiple sclerosis
- •Amyotrophic lateral sclerosis
- •History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems.
- •Self-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device.
- •Unwillingness to complete the required assessments.
- •Patient is not capable of giving informed consent or unable to comprehend and/or follow instructions.
结局指标
主要结局
Examination of the quantitative training program progression data
Safety
次要结局
- Perceived stress assessments
- Quality of life health assessments
- Functional outcomes assessments