The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To measure the change in fatigue after three months between the intervention and control arm
研究概览
简要总结
This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.
详细描述
The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ Age 60 years (no upper age limit)
- •Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
- •Able to read English (required for CGA and other surveys administered)
- •Approval from their treating physician to engage in moderate-intensity physical activity
- •Patient-assessed ability to walk and engage in moderate physical activity
- •Signed, IRB-approved written informed consent
排除标准
- •Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
- •Already walking or engaging in other physical activity >120 minutes per week as documented via subject self-report
- •Unable to walk or engage in moderate-intensity physical activity
- •One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
结局指标
主要结局
To measure the change in fatigue after three months between the intervention and control arm
时间窗: Three Months
The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
次要结局
- To measure changes in physical function at baseline between the intervention and control groups.(4 to 24 weeks)
- To measure adherence to the physical activity intervention(One Year)
- To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy(Six months)
- To measure changes in ADLs at baseline between the intervention and control groups.(4 to 24 weeks)
- To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.(4 to 24 weeks)
- To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups(One Year)
- To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms(One Year)
- To measure changes in Quality of Life at baseline between the intervention and control groups.(4 to 24 weeks)
- To measure changes in Self-Efficacy at baseline between the intervention and control groups.(4 to 24 weeks)