NCT07737951

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
35mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Jun 2029

First Submitted

Initial submission to the registry

May 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

May 20, 2026

Last Update Submit

July 27, 2026

Conditions

Hormone Receptor Positive Breast CarcinomaPostmenopausalBreast Cancer

Keywords

AnatrozoleLetrozoleExemestaneTai Chi

Outcome Measures

Primary Outcomes (3)

  • Consent Rate

    Percentage of eligible participants who consent and enroll in the study.

    Up to 6 months

  • Engagement Rate

    Percentage of intervention sessions attended by enrolled participants.

    12 weeks

  • Retention Rate

    Percentage of participants completing study follow up assessments.

    20 weeks

Secondary Outcomes (2)

  • Client Satisfaction Questionnaire Score

    12 weeks

  • Patient Perceived Credibility of the Intervention

    12 weeks

Study Arms (2)

TaiChi4Joint

EXPERIMENTAL

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 Control

ACTIVE 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

Interventions

Tai ChiBEHAVIORAL

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.

Also known as: TaiChi4Joint
TaiChi4Joint
Health EducationBEHAVIORAL

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

Also known as: Health Education Attention Control Group
Health Education Attention Control

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInvestigators have decided to limit eligibility to women with BCa because a) \< 1% of BCa diagnosis are made in men and b) limited information is available on AIIA among male BCa patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Kuang-Yi Wen, PhD

    Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Yi Wen, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

July 30, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2029

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

US(1)