Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial

April 28, 2025 updated by: Thomas Jefferson University

Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients

This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week Tai Chi intervention for relieving aromatase inhibitor (AI)-induced arthralgia in women with breast cancer (BCa).

OUTLINE:

Patients attend Tai Chi exercise classes over 1 hour twice weekly (BIW) and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be able to speak and read English
  • Been diagnosed with stage I-III breast cancer (BC)
  • Had completed all active treatments
  • Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months
  • Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI
  • Report worst pain in the past week >= 4 on a 0-10 numeric rating scale
  • Be willing to adhere to all study procedures

Exclusion Criteria:

  • Has been diagnosed with another form of cancer in the past 5 years
  • Uncontrolled cardiac, pulmonary, or infectious disease
  • Body mass index (BMI) > 40 kg/m^2
  • Currently attending any mind-body therapy classes (e.g. yoga)
  • Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data)
  • Had surgery or joint infection in the past 6 months
  • Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)
Patients attend Tai Chi exercise classes over 1 hour BIW and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Tai Chi
Attend Tai Chi exercise classes
Device: FitBit
Wear FitBit
Other: Support Group Therapy
Join Tai4Chijoint group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tai Chi practice
Time Frame: Up to 12 weeks
Diary log form.
Up to 12 weeks
Tai Chi practice
Time Frame: Up to 12 weeks
Examples include documenting potential issues that participants think might be intervention-related.
Up to 12 weeks
Assess the client's perspective on the value of services received
Time Frame: Up to 36 weeks
Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.
Up to 36 weeks
Lower-extremity joint symptoms
Time Frame: Up to 12 weeks
Western Ontario and McMaster Universities Arthritis Index will be used to assess pain in the past 7 days in three domains: pain, stiffness, and physical function; higher scores indicating worse pain, stiffness, and functional limitations.
Up to 12 weeks
Pain, stiffness, and physical function in the hands
Time Frame: Up to 12 weeks
Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Up to 12 weeks
Assess pain, pain severity, and pain interference
Time Frame: up to 12 weeks
Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
up to 12 weeks
Fatigue
Time Frame: Up to 12 weeks
Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
Up to 12 weeks
Effects of Hot Flashes on Quality of life
Time Frame: Up to 12 weeks
Hot Flash Related Daily Interference Scale will be used to measure the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life.
Up to 12 weeks
Assessment of Sleep quality
Time Frame: Up to 12 weeks
Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.
Up to 12 weeks
Cancer-related distress
Time Frame: Up to 12 weeks
Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20G.093
  • NCI-2020-02555 (Other Identifier: The Buck Foundation)
  • JT 14910 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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