Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Rate of Study Enrollment
研究概览
简要总结
The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.
详细描述
The study uses a single-arm design. All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up). Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with stage 0-III breast cancer
- •Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously
- •Are post-menopausal defined as defined as no menses in the past 12 months
- •Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician
- •Report joint pain that started or worsened after initiation of AI medication
- •Report worst pain score > 4 in the preceding week on an 11-point (0-10) numeric rating scale
排除标准
- •Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years
- •Have uncontrolled cardiac disease, pulmonary disease, or infectious disease
- •Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea)
- •Have a body mass index (BMI) > 40 kg/m^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses)
- •Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history
- •Had surgery within the past 3 months
- •Had injections of medication within the last 3 months to joint(s) currently painful
- •Are currently using corticosteroids or opioid medications
- •Are currently attending yoga classes
- •Do not speak or read standard English
- •Are scheduled or are planning to discontinue AI medication in the next 16 weeks
- •Do not have sufficient access to the Internet to complete study assessments
结局指标
主要结局
Rate of Study Enrollment
时间窗: 24 months
Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.
Rate of Study Completion
时间窗: Up to 24 weeks per participant
Feasibility of the proposed study assessment and intervention methods. The study methods will be considered feasible if 70% or more of consented participants complete both the baseline and follow-up assessments and attend an average of 70% or more of scheduled yoga classes.
次要结局
- Occurrence of Reduced Pain Severity(Up to 24 weeks per participant)
- Occurrence of Relief from Other Side Effects(Up to 24 weeks per participant)