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

NCT ID: NCT04716920

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2021-12-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tai Chi

Intervention Type OTHER

Attend Tai Chi exercise classes

FitBit

Intervention Type DEVICE

Wear FitBit

Support Group Therapy

Intervention Type OTHER

Join Tai4Chijoint group

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Tai Chi

Attend Tai Chi exercise classes

Intervention Type OTHER

FitBit

Wear FitBit

Intervention Type DEVICE

Support Group Therapy

Join Tai4Chijoint group

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35727609 (View on PubMed)

Other Identifiers

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NCI-2020-02555

Identifier Type: OTHER

Identifier Source: secondary_id

JT 14910

Identifier Type: OTHER

Identifier Source: secondary_id

20G.093

Identifier Type: -

Identifier Source: org_study_id

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