Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Markers of inflammation: C-reactive protein
研究概览
简要总结
The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.
详细描述
The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group.
Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.
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
- 65 Years 至 84 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 65-84 years
- •1-10 years post-breast cancer treatment
- •Body mass index ≥30
- •≥1 drink per week over the last month
- •≥21 on the Telephone Interview For Cognitive Status
- •≤7 on the Alcohol Use Disorder Identification Test
- •Fluent in written and spoken English
- •Must be able to provide and understand informed consent
- •Primary physician approval
排除标准
- •Body mass index <30
- •< 21 on the Telephone Interview for Cognitive Status
- •>7 on the Alcohol Use Disorder Inventory Test
- •Other neurological or major psychiatric disorders
- •Significant heart or lung disease
- •Limited life expectancy
- •Other factors that could potentially limit ability to participate fully in the intervention
- •Self-reporting achieving over 150 minutes of moderate-to-vigorous physical activity per week.
结局指标
主要结局
Markers of inflammation: C-reactive protein
时间窗: 15 weeks
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
次要结局
- Fatigue(15 weeks)
- Sleep Disturbance(Baseline)
- Ability to Participate in Social Roles and Activities(15 weeks)
- Physical Function-walk test(15 weeks)
- Depressive Symptoms(15 weeks)
- Physical Function-The Patient-Reported Outcomes Measurement Information System(15 weeks)
- Pain intensity(15 weeks)
- Anxiety Symptoms-State-Trait Anxiety Inventory(15 weeks)
- Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System(15 weeks)
- Pain interference(15 weeks)
- Alcohol consumption(15 weeks)
- Mobile Monitoring of Cognitive Change(Week 14-15)
- The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments(15 weeks)
- The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities(15 weeks)
- Markers of inflammation-Interleukin 6(15 weeks)
- Markers of inflammation-Tumor Necrosis Factor Alpha(15 weeks)
- The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life(15 weeks)
- The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others(15 weeks)
- Sleep Disturbance-PROMIS-57(15 weeks)
- Telephone Interview for Cognitive Status(Baseline)
- Demographics(Baseline)
- Alcohol consumption-daily(Week 14-15)
- Alcohol Use Disorder(Baseline)
- Acceptability-the proportion of older adults who agree to participate(Baseline)
- Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention(Week 15)
研究者
Christopher Sciamanna, MD, MPH
Professor
Penn State Health Milton S Hershey Medical Center