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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04716920
Enrollment
39
Registered
2021-01-20
Start date
2020-03-11
Completion date
2021-12-23
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.

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.

Interventions

OTHERTai Chi

Attend Tai Chi exercise classes

DEVICEFitBit

Wear FitBit

Join Tai4Chijoint group

OTHERQuestionnaire Administration

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tai Chi practiceUp to 12 weeksDiary log form.
Assess the client's perspective on the value of services receivedUp to 36 weeksWill be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.
Lower-extremity joint symptomsUp to 12 weeksWestern 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.
Pain, stiffness, and physical function in the handsUp to 12 weeksAustralian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Assess pain, pain severity, and pain interferenceup to 12 weeksBrief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
FatigueUp to 12 weeksFatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
Effects of Hot Flashes on Quality of lifeUp to 12 weeksHot 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.
Assessment of Sleep qualityUp to 12 weeksPittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.
Cancer-related distressUp to 12 weeksCenters for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026