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

Thomas Jefferson University

Status: Completed

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

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Support Group Therapy; Device: FitBit; Other: Tai Chi

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04716920

20G.093

NCI-2020-02555 (Other Identifier)

JT 14910 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)

Experimental group

Description:

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.

Treatment:

Other: Tai Chi

Device: FitBit

Other: Support Group Therapy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment