Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Self-reported joint pain
研究概览
简要总结
For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks
- •Experiencing more than mild joint pain/symptoms
- •21 or older
- •have permission from physician to engage in moderate intensity physical activity
排除标准
- •Undergoing chemotherapy and/or radiation therapy at any time during the study period
- •Scheduled for major surgery during the study period
- •Presently engaged in high levels of physical activity on a daily basis
- •Less than 21 years of age
- •Unable to walk or engage in moderate intensity physical activity
研究组 & 干预措施
Walking
Walk with Ease
干预措施: Walk with Ease (Behavioral)
Wait list control
Wait list control receiving the active intervention 6 weeks later.
结局指标
主要结局
Self-reported joint pain
时间窗: 6 weeks
A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials.
次要结局
- Self-reported walking(6 weeks)
研究者
Leigh F Callahan, PhD
Mary Link Briggs Distinguished Professor of Medicine
University of North Carolina, Chapel Hill