Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer
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
研究组 & 干预措施
Computerized cognitive treatment
Chosen exercises from the rehabilitation package of a commercially available, computerized, cognitive training program called Happy Neuron Pro will be used. This program was designed by a team of neurologists, neuropsychologists and cognitive psychologists, and has been successfully adapted for varying conditions of cognitive dysfunction.
干预措施: Computerized cognitive treatment (Behavioral)
Wait list control
Participants assigned to the wait list control arm will receive no treatment while the experimental arm is participating in the computerized treatment. However, the computerized treatment program will be made available for these participants to utilize at the end of the study period.
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)