Recruiting

TaiChi4Joint vs. HE AC

Sponsor:

Thomas Jefferson University

Code:

NCT07737951

Conditions

Hormone Receptor Positive Breast Carcinoma

Postmenopausal

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tai Chi

Health Education

Study Details

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

Study ID

NCT07737951

Start date

Jul 27, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: TaiChi4Joint

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).

active comparator: Health Education Attention Control

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.

Interventions

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.

Health Education

Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.

Primary outcome measure

  • Consent Rate [ Time Frame: Up to 6 months ]
  • Engagement Rate [ Time Frame: 12 weeks ]
  • Retention Rate [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Kuang-Yi Wen, PhD

215-503-4623Kuang-Yi.Wen@Jefferson.edu

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Kuang-Yi Wen, MD

2155034623Kuang-Yi.Wen@Jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Anatrozole
  • Letrozole
  • Exemestane
  • Tai Chi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-08-14.