AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8NCT04716920

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

A study testing Tai Chi, FitBit and Support Group Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Tai Chi, FitBit and Support Group Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
11 Mar 2020to 23 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Tai Chi, FitBit, Support Group Therapy, Questionnaire Administration, Quality-of-Life Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai ChiOther

    Attend Tai Chi exercise classes

  • FitBitDevice

    Wear FitBit

  • Support Group TherapyOther

    Join Tai4Chijoint group

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT04716920
Study groupRoleWhat they receive
Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)ExperimentalPatients 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.
Receives: Other: Tai Chi; Device: FitBit; Other: Support Group Therapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tai Chi practice

    Diary log form.

    Measured: Up to 12 weeks

  2. Tai Chi practice

    Examples include documenting potential issues that participants think might be intervention-related.

    Measured: Up to 12 weeks

  3. Assess the client's perspective on the value of services received

    Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.

    Measured: Up to 36 weeks

  4. Lower-extremity joint symptoms

    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.

    Measured: Up to 12 weeks

  5. Pain, stiffness, and physical function in the hands

    Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.

    Measured: Up to 12 weeks

  6. Assess pain, pain severity, and pain interference

    Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.

    Measured: up to 12 weeks

  7. Fatigue

    Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.

    Measured: Up to 12 weeks

  8. Effects of Hot Flashes on Quality of life

    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.

    Measured: Up to 12 weeks

  9. Assessment of Sleep quality

    Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.

    Measured: Up to 12 weeks

  10. Cancer-related distress

    Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start11 Mar 2020
  3. Primary completion21 Jul 2021
  4. Study completion23 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716920
Sponsor's protocol ID
20G.093
Other IDs
NCI-2020-02555, JT 14910
Status last verified
Apr 2025
First submitted
7 Dec 2020
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gomaa S, West C, Lopez AM, Zhan T, Schnoll M, Abu-Khalaf M, Newberg A, Wen KY. A Telehealth-Delivered Tai Chi Intervention (TaiChi4Joint) for Managing Aromatase Inhibitor-Induced Arthralgia in Patients With Breast Cancer During COVID-19: Longitudinal Pilot Study. JMIR Form Res. 2022 Jun 21;6(6):e34995. doi: 10.2196/34995.

    PubMed 35727609

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi, FitBit and Support Group Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tai Chi practice (time frame: Up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in