Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Consent Rate
研究概览
简要总结
The objective of the pilot RCT is to evaluate the feasibility and acceptability of a Tai Chi intervention "TaiChi4Joint" vs. an HE AC group for relieving AIIA in women with hormone receptor positive stage I-III BCa. The investigators will pilot test our data collection for mechanism measures via three innovatively integrated biobehavioral pathways.
详细描述
40 patients from Thomas Jefferson University with a diagnosis of stage I-III hormone receptor-positive breast cancer who are postmenopausal, currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation, report joint pain that started or worsened after initiation of AI therapy, and report worst pain in the past week of ≥3 on the Brief Pain Inventory (BPI) 0-10 scale, indicating at least moderate pain. Eligible participants must be able to complete study procedures in English, be willing to be randomized in a 1:1 ratio to the intervention or attention control group, and adhere to study procedures. Participants will be excluded if they are currently engaged in regular structured moderate- or vigorous-intensity exercise totaling ≥150 minutes per week over the past 3 months, or participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months.
BCa patients with AIIA during the first 2 years of AI initiation will be equally randomized to either the TaiChi4Joint group or a health education AC group for 12 weeks.
TaiChi4Joint Group: Routine virtual Tai Chi group classes via Zoom for 1 hour, twice a week, for 12 weeks, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow-up. Health Education Attention Control Group: Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
Primary Objectives: Examine the feasibility and acceptability of the RCT design and implementation Feasibility will be measured through consent rate, treatment attendance and retention.
Secondary Objectives: Examine the acceptability of the interventions. Acceptability will be indicated by participants-reporting treatment satisfaction using a standardized measure. Patient perceived creditability of the intervention, and patients' fidelity of the intervention and teleassessment will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- •Age ≥18 years
- •Diagnosis of stage I-III hormone receptor-positive breast cancer
- •Postmenopausal
- •Currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation
- •Report joint pain that started or worsened after initiation of AI therapy
- •Report worst pain in the past week ≥3 on the BPI (0-10 scale)
- •Able to complete study procedures in English
- •Willing to be randomized to an intervention or attention control group and adhere to study procedures
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Undergoing active cancer treatment (excluding endocrine therapy)
- •Uncontrolled cardiac or pulmonary disease that would limit safe participation
- •Currently engaged in regular structured moderate- or vigorous-intensity exercise (e.g., brisk walking, jogging/running, cycling, swimming, aerobic classes, or resistance training) totaling ≥150 minutes per week over the past 3 months
- •Currently participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months
- •Joint pain due to inflammatory arthritic conditions
- •Recent surgery or joint injection within the past 4-6 weeks
- •Initiation or dose change of corticosteroids or opioids within the past 4 weeks
- •Planned discontinuation of AI therapy within the next 6 months
- •This study is limited to women with breast cancer, as <1% of cases occur in men and data on AIIA in male patients are limited
研究组 & 干预措施
TaiChi4Joint
Participants randomized to the TaiChi4Joint group will attend virtual Tai Chi classes via Zoom (1 hour, twice weekly for 12 weeks). At the first class, participants will review a Tai Chi safety and modifications handout. Using a manualized approach, each session includes structured objectives and activities to progressively learn simplified Tai Chi forms, with weekly verification of skill attainment. Six core elements are emphasized: (1) mindfulness (present-focused attention); (2) postural alignment (efficient, upright movement); (3) natural breathing (integrated with movement); (4) active relaxation (remaining relaxed while moving); (5) slow movement (building strength and endurance); and (6) integrated movement (coordinating functional movements).
干预措施: Tai Chi (Behavioral)
Health Education Attention Control
To control for the attention that the TaiChi4Joint group receives, women randomized to the AC group will participate Routine virtual AC group classes via Zoom or via video link for 1 hour, twice a week, for 12 weeks, including survivorship content or healthy eating.
The AC group is designed to control for attention and for expectations about getting some benefits from the treatment. The AC group is controlled for time and will also be 1 hour each time, twice a week, matching the frequencies and intensity of the intervention group.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Consent Rate
时间窗: Up to 6 months
Percentage of eligible participants who consent and enroll in the study.
Engagement Rate
时间窗: 12 weeks
Percentage of intervention sessions attended by enrolled participants.
Retention Rate
时间窗: 20 weeks
Percentage of participants completing study follow up assessments.
次要结局
- Client Satisfaction Questionnaire Score(12 weeks)
- Patient Perceived Credibility of the Intervention(12 weeks)