Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Proportion of randomized patients who are still on study at the end of the 12 week intervention
研究概览
简要总结
This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors.
SECONDARY OBJECTIVE:
I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm.
OUTLINE: Participants are randomized into 1 of 5 arms.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- •Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa)
- •Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise)
- •Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM)
排除标准
- •Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Are pregnant or nursing
- •Are unwilling or unable to follow protocol requirements
- •Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
- •Have metastatic breast cancer
- •Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
结局指标
主要结局
Proportion of randomized patients who are still on study at the end of the 12 week intervention
时间窗: At 12 weeks
The feasibility outcomes will be assessed by a multivariable logistic regression model for the relative odds of remaining on the study (ref: not). Each of the active treatment arms will be compared to the control. The model will be supported by the randomized patient set, counting patients who withdraw from the study as feasibility failures. No variable selection steps will be taken; inferences will be based on the estimates and 95% confidence intervals from the full model. Optimism adjusted odds ratio estimates will also be reported, to better inform design of future studies.
次要结局
- Adherence rate in each of the active intervention arms(Up to 12 weeks)