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
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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COMPLETED
NA
39 participants
INTERVENTIONAL
2020-03-11
2021-12-23
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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.
Tai Chi
Attend Tai Chi exercise classes
FitBit
Wear FitBit
Support Group Therapy
Join Tai4Chijoint group
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Tai Chi
Attend Tai Chi exercise classes
FitBit
Wear FitBit
Support Group Therapy
Join Tai4Chijoint group
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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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.
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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