NCT03017560已完成不适用
Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Verbal Memory
研究概览
简要总结
The primary purpose of this study is to test the effects of a targeted, computerized cognitive training program on verbal memory in older women who have undergone chemotherapy treatment for early-stage breast cancer. As measured by neuropsychological assessment, this treatment will result in improved verbal memory. Secondarily, processing speed and naming abilities are expected to improve. Enhanced self-perception of cognitive ability is also expected.
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
- 65 Years 至 90 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 65-90
- •Chemotherapy treatment for early-stage (I, IIa, IIb, IIIa) breast cancer
- •Post-menopausal
- •High school education or greater
- •Geographically available for followup assessment
- •Native English speaker
- •Normal or corrected to near-normal hearing and vision
排除标准
- •Psychiatric history including past or current psychotic spectrum disorders (schizophrenia, bipolar disorder, major depressive disorder, dementia, schizoaffective disorder)
- •Brain injury (e.g., stroke, heart attack, aneurysm, tumor, concussion, head trauma)
- •Brain disease
- •History of brain irradiation or surgery
- •Current or past disease/disorder of the central nervous system or medical condition affecting cognitive functioning (e.g., chronic migraine, epilepsy or history of seizures, encephalitis, meningitis, multiple sclerosis, thyroid condition, Parkinson's, Alzheimer's, Huntington's disease)
- •Active diagnosis of autoimmune or inflammatory disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, insulin-dependent diabetes, Crohn's disease, uncontrolled allergic reaction or asthma)
- •History of other cancer, except for basal cell carcinoma
- •Development of a second primary malignancy during the study
- •Drug or alcohol abuse (i.e., more than 7 drinks per week)
- •Chronic use of oral steroid medication
- •Former (prior to early-stage breast cancer) intrathecal therapy, radiation therapy, chemotherapy, or any neoadjuvant chemotherapy
- •Acquired or developmental speech, language, or learning disorders (e.g., aphasia, dyslexia, dysgraphia, auditory processing disorder, autism, developmental delay)
- •Hormone replacement therapy, excluding vaginal estrogen
结局指标
主要结局
Verbal Memory
时间窗: Change in Verbal Memory scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks.
Immediate and delayed verbal memory
次要结局
- Processing Speed measured via Lexical Decision Task(Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks)
- Processing Speed measured via Stroop Color-Word Test(Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks)
研究者
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