Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia

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.

• Tai Chi (Behavioral), also known as TaiChi4Joint: 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 (Behavioral), also known as 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 outcomes

• Consent Rate [Up to 6 months]: Percentage of eligible participants who consent and enroll in the study.
• Engagement Rate [12 weeks]: Percentage of intervention sessions attended by enrolled participants.
• Retention Rate [20 weeks]: Percentage of participants completing study follow up assessments.

Secondary outcomes

• Client Satisfaction Questionnaire Score [12 weeks]: Participant reported satisfaction with the intervention measured using the Client Satisfaction Questionnaire. Acceptability will be 1) 80% of participants report a mean score of 4 or higher on participants' responses to study acceptability items on the Client Satisfaction Questionnaire. Client Satisfaction Questionnaire - 8 Item Version (CSQ-8) is a standardized measure of global satisfaction with services. It consists of 8 items, each rated on a 4-point Likert scale, with responses summed to yield a total score ranging from 8 (minimum) to 32 (maximum). Higher scores indicate a better outcome, reflecting greater client satisfaction with the services received.
• Patient Perceived Credibility of the Intervention [12 weeks]: Primary benchmark for Credibility will be 2) a mean score of 4 or higher on participants 'responses to study items from the Credibility/Expectancy Questionnaire. 3) Chi-square tests will compare feasibility metrics by White vs. AA patients. Quantitative acceptability ratings will be summarized. The Credibility/Expectancy Questionnaire (CEQ) is a measure of treatment credibility and expectancy for improvement. It includes a Credibility subscale (3 items scored on a 1-9 scale) with total scores ranging from 3 (minimum) to 27 (maximum), and an Expectancy subscale (2 items scored on a 0-100 scale) with scores typically averaged to yield a range from 0 (minimum) to 100 (maximum). For both subscales, higher scores indicate a better outcome, reflecting greater perceived credibility of the intervention and stronger expectations that the treatment will be effective.

Sex: Female, ages: 18 Years to any

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

• Kuang-Yi Wen, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University