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.
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.
Eligibility
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
