Physical Activity and Neuropsychological Outcomes in a Cancer Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
研究概览
简要总结
Many cancer survivors experience treatment-related impairments in mental abilities such as memory, attention, and concentration (known as cognition). Research indicates that physical activity can improve cognition in healthy adults; however, little is known about whether physical activity can improve cognition among cancer survivors. This study will test whether a physical activity intervention results in improvements in cognition among breast cancer survivors, which may lead to interventions to improve cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer survivors; diagnosed at stage 1, 2, or 3 less than 5 years ago -
- •not scheduled for or currently undergoing chemotherapy; sedentary, defined as engaging in less than 60 minutes of moderate to vigorous physical activity each week
- •accessible geographically and by telephone
- •have access to the internet
- •endorse experience difficulties with thinking abilities
- •in addition, participants on adjuvant therapy (e.g., tamoxifen or aromatase inhibitors) must be able and willing to remain on that treatment for the 3-month intervention period to prevent confounding of biomarker concentrations by treatment.
排除标准
- •history of coronary heart disease, diabetes, stroke, orthopedic conditions that limit mobility, or any other serious medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- •other primary or recurrent invasive cancer within the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
- •unable to commit to a 3-month intervention schedule; any condition that, in the investigators' judgment, would contraindicate increased physical activity or otherwise interfere with participation in the trial
- •unable to provide a blood sample at the baseline measurement visit
- •unable to speak and read English.
研究组 & 干预措施
Exercise Intervention
This arm will receive a 12-week individually tailored phone and email-based exercise program.
干预措施: Exercise (Behavioral)
Wellness Waitlist Control
This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.
干预措施: Control (Behavioral)
结局指标
主要结局
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
时间窗: Baseline to 12 weeks
Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.
次要结局
未报告次要终点
研究者
Sheri Hartman
Assistant Professor
University of California, San Diego