Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Physical Activity Level
研究概览
简要总结
The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.
详细描述
The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors. Participants will undergo baseline testing at Dana-Farber or Yale, including administration of questionnaires to assess quality of life and the presence of cancer and treatment-related symptoms, fasting blood draw, and evaluation of body composition (using dual energy X-ray absorptiometry (DEXA). Participants will then take part in the 12-week LIVESTRONG Program or will be assigned to a wait-list control group. All measurements will be repeated at Dana-Farber or Yale after the 12-week exercise program or control period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer diagnosis excluding non-melanoma skin cancer
- •Physically able to exercise
- •Able to complete forms and understand instructions in English
- •Agrees to be randomly assigned to either exercise or wait-list control group
- •Willing and able to attend one of the LIVESTRONG at the YMCA programs for 12 weeks
- •Willing and able to complete the baseline and 3-month clinic visits
排除标准
- •> 80 years of age
- •< 18 years of age
- •Recent (past 6 months) stroke/myocardial infarction or congestive heart failure/documented ejection fraction < 40%
- •Plans to undergo a major surgical procedure in the next 6 months
- •Presence of dementia or major psychiatric disease that would preclude participation in a group-based exercise program
- •Pregnant women or women intending to become pregnant
研究组 & 干预措施
LIVESTRONG Program
Participants randomized to the LIVESTRONG exercise program will attend a 12-week LIVESTRONG Program at one of the participating YMCA's in the greater Boston area or CT. We will have monthly teleconferences to discuss the study, recruitment, and the exercise program. Lastly, throughout the 12-week program, participants will record their attendance at the LIVESTRONG program as well as any exercise done outside of the program. We will provide them with a Physical Activity Log book to record their exercise.
干预措施: LIVESTRONG (Behavioral)
Wait-List Control
Baseline data will be collected from all study participants before randomization. If a participant is randomized to wait-list control, then he/she will be told that he/she will start the LIVESTRONG program after three months and after he/she returns to Yale or DFCI to complete the 3-month clinic visit.
结局指标
主要结局
Change in Physical Activity Level
时间窗: 3 months
Modifiable Physical Activity Questionnaire will be used to assess physical activity levels at baseline and 3-months to examine whether the LIVESTRONG program led to maintenance or further increases in physical activity levels compared with participants randomized to control.
次要结局
- Change in Blood Biomarkers(12 weeks)
- Change in Body Fat Percentage(3 months)
- Change in Lean Body Mass(3 months)
- Change in Bone Mineral Density(3 months)
- Change in Body Mass Index (BMI)(3 months)