Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia

Official title

Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

Overview

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.

Detailed description

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.

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]
• Engagement Rate [Time frame: 12 weeks]
• Retention Rate [Time frame: 20 weeks]

Secondary outcome measures (2)

• Client Satisfaction Questionnaire Score [Time frame: 12 weeks]
• Patient Perceived Credibility of the Intervention [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT07737951 · iRIS-ID-2025-0036 · JT 44717

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗