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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

March 11, 2020

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed

Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

December 7, 2020

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

Tai Chi practice
Diary log form.
Up to 12 weeks
Tai Chi practice
Examples include documenting potential issues that participants think might be intervention-related.
Up to 12 weeks
Assess the client's perspective on the value of services received
Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.
Up to 36 weeks
Lower-extremity joint symptoms
Western 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.
Up to 12 weeks
Pain, stiffness, and physical function in the hands
Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Up to 12 weeks
Assess pain, pain severity, and pain interference
Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
up to 12 weeks
Fatigue
Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
Up to 12 weeks
Effects of Hot Flashes on Quality of life
Hot 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.
Up to 12 weeks
Assessment of Sleep quality
Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.
Up to 12 weeks
Cancer-related distress
Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.
Up to 12 weeks

Study Arms (1)

Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)

EXPERIMENTAL

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.

Other: Tai ChiDevice: FitBitOther: Support Group TherapyOther: Questionnaire AdministrationOther: Quality-of-Life Assessment