试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Standardized Executive Function Test Composite Score
研究概览
简要总结
This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.
详细描述
PRIMARY OBJECTIVES:
I. To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms.
ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of breast cancer
- •Received chemotherapy treatment for breast cancer diagnosis
- •Chemotherapy-free for at least one year
排除标准
- •History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
- •Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
- •Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
- •Pregnancy
结局指标
主要结局
Standardized Executive Function Test Composite Score
时间窗: Baseline to 3 months
次要结局
未报告次要终点