改善癌症后的认知 (I Can!)
一项针对乳腺癌幸存者认知功能的身体活动的随机试验
This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
研究概览
详细说明
Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.
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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California
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La Jolla、California、美国、92093
- Moores UCSD Cancer Center
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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:
- breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
- self-report difficulties with cognition since their cancer diagnosis
- self-report low levels of moderate to vigorous physical activity
- have a Fitbit compatible device with internet
- breast cancer was treated with chemotherapy and/or hormonal therapy
Exclusion Criteria:
- medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
- unable to commit to a 12-month study
学习计划
研究是如何设计的?
设计细节
- 主要用途: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 |
|---|---|
|
实验性的:Exercise Intervention
This arm will receive a 12-month individually tailored phone and email-based exercise program. |
This intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity |
|
有源比较器:Health & Wellness Intervention
This arm will receive a 12-month health and wellness program. |
This intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions |
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 |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digit Test
大体时间:Baseline to 6 months
|
The NIH Toolbox Oral Symbol Digit Test is a measure of processing speed, administered on an iPad by trained staff. Participants view a key pairing nine abstract symbols with the digits 1-9 and say aloud the digit that matches each symbol in a series, completing as many items as possible in 120 seconds. Higher scores indicate faster processing speed. |
Baseline to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
大体时间:Baseline to 12 months
|
The NIH Toolbox Oral Symbol Digit Test is a measure of processing speed, administered on an iPad by trained staff. Participants view a key pairing nine abstract symbols with the digits 1-9 and say aloud the digit that matches each symbol in a series, completing as many items as possible in 120 seconds. Higher scores indicate faster processing speed. |
Baseline to 12 months
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities
大体时间:Baseline to 6 months and Baseline to 12 months
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Cognitive Function - Abilities Subset, administered as a computerized adaptive test (CAT), which assesses self-perceived cognitive abilities (e.g., memory, attention, and concentration) in daily life. Raw scores are converted to T-scores, standardized to a mean of 50 and standard deviation of 10 in the U.S. general population reference sample. Higher T-scores indicate better self-reported cognitive function. |
Baseline to 6 months and Baseline to 12 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Hartman SJ, Shao LY, Zablocki RW, Natarajan L, Ahles T, Palmer BW, Sears DD, Tam RM, Mac V, Dillon L, Yan C, Parker BA. Effectiveness of an exercise intervention on cognition in breast cancer survivors: a randomized controlled trial. J Natl Cancer Inst. 2026 Sep 30:djag295. doi: 10.1093/jnci/djag295. Online ahead of print.
- Carlin D, Ott O, Sears DD, Ahles T, Desplats P, Hartman SJ. Exercise slows biological aging in breast cancer survivors: secondary analysis of a randomized trial. J Natl Cancer Inst. 2026 Sep 30:djag296. doi: 10.1093/jnci/djag296. Online ahead of print.
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
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
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