Clinical trial NCT04716920: Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial
Official title: Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-01-20
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tai Chi practice
timeFrame: Up to 12 weeks
measure: Tai Chi practice
timeFrame: Up to 12 weeks
measure: Assess the client's perspective on the value of services received
timeFrame: Up to 36 weeks
measure: Lower-extremity joint symptoms
timeFrame: Up to 12 weeks
measure: Pain, stiffness, and physical function in the hands
timeFrame: Up to 12 weeks
measure: Assess pain, pain severity, and pain interference
timeFrame: up to 12 weeks
measure: Fatigue
timeFrame: Up to 12 weeks
measure: Effects of Hot Flashes on Quality of life
timeFrame: Up to 12 weeks
measure: Assessment of Sleep quality
timeFrame: Up to 12 weeks
measure: Cancer-related distress
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
citation: 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.