Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Assess the client's perspective on the value of services received
研究概览
简要总结
This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week Tai Chi intervention for relieving aromatase inhibitor (AI)-induced arthralgia in women with breast cancer (BCa).
OUTLINE:
Patients attend Tai Chi exercise classes over 1 hour twice weekly (BIW) and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.
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
- •Be able to speak and read English
- •Been diagnosed with stage I-III breast cancer (BC)
- •Had completed all active treatments
- •Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months
- •Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI
- •Report worst pain in the past week >= 4 on a 0-10 numeric rating scale
- •Be willing to adhere to all study procedures
排除标准
- •Has been diagnosed with another form of cancer in the past 5 years
- •Uncontrolled cardiac, pulmonary, or infectious disease
- •Body mass index (BMI) > 40 kg/m^2
- •Currently attending any mind-body therapy classes (e.g. yoga)
- •Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data)
- •Had surgery or joint infection in the past 6 months
- •Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months
结局指标
主要结局
Assess the client's perspective on the value of services received
时间窗: Up to 36 weeks
Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.
Assessment of Sleep quality
时间窗: Up to 12 weeks
Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.
Cancer-related distress
时间窗: Up to 12 weeks
Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.
Assess pain, pain severity, and pain interference
时间窗: up to 12 weeks
Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
Fatigue
时间窗: Up to 12 weeks
Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
Lower-extremity joint symptoms
时间窗: Up to 12 weeks
Western Ontario and McMaster Universities Arthritis Index will be used to assess pain in the past 7 days in three domains: pain, stiffness, and physical function; higher scores indicating worse pain, stiffness, and functional limitations.
Pain, stiffness, and physical function in the hands
时间窗: Up to 12 weeks
Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Effects of Hot Flashes on Quality of life
时间窗: Up to 12 weeks
Hot Flash Related Daily Interference Scale will be used to measure the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life.
Tai Chi practice
时间窗: Up to 12 weeks
Diary log form.
次要结局
未报告次要终点