NCT07737951 · Thomas Jefferson University
Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Tai Chi
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.
BEHAVIORAL
Health Education
Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
Primary outcome measures
Consent Rate
Time frame: Up to 6 months
Percentage of eligible participants who consent and enroll in the study.
Engagement Rate
Time frame: 12 weeks
Percentage of intervention sessions attended by enrolled participants.
Retention Rate
Time frame: 20 weeks
Percentage of participants completing study follow up assessments.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- -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
Exclusion criteria
- -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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations