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NCT07737951

Overview

NCT ID: NCT07737951
Lead Sponsor: Thomas Jefferson UniversityOTHER
Official Title: Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
Brief Summary: 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.
Conditions: Hormone Receptor Positive Breast Carcinoma
Postmenopausal
Breast Cancer
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Jun 2026Estimated
Primary Completion Date: Jun 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Kuang-Yi Wen, PhDContact
Kuang-Yi.Wen@Jefferson.edu215-503-4623

Similar Studies

Participant Group/Arms

TaiChi4JointExperimental

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).

Behavioral: Tai Chi

Health Education Attention ControlActive Comparator

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.

Behavioral: Health Education