Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in pro-inflammatory and anti-inflammatory cytokines
研究概览
简要总结
It is important to confirm health benefits experienced by breast cancer survivors after participation in a physical activity behavior change intervention. One such potential benefit is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk. Because little is known about how physical activity behavior change interventions influence inflammation in breast cancer survivors, the investigators study will measure inflammation with blood markers known as cytokines among breast cancer survivors before and after a physical activity intervention. Such information has the potential to lead to improved physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer risk in breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are not currently receiving (and do not plan to receive during the study duration) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
- •If the patient has undergone a surgical procedure, must be at least 8 weeks post-procedure.
- •English speaking.
- •Medical clearance for participation provided by primary care physician or oncologist.
排除标准
- •Diagnosis of dementia or organic brain syndrome.
- •Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
- •Contraindication to participation in a regular physical activity program.
- •Metastatic or recurrent disease
- •Inability to ambulate
- •Engaged in ≥ 60 minutes of vigorous physical activity or ≥ 150 minutes of moderate plus vigorous activity per week during the past month.
- •Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
- •Participant does not live or work within 50 miles of the study site.
结局指标
主要结局
Change in pro-inflammatory and anti-inflammatory cytokines
时间窗: baseline and 3 months
次要结局
- Change in fatigue, sleep and muscle strength(baseline and 3 months)
研究者
Laura Q. Rogers, MD, MPH
Professor
University of Alabama at Birmingham