Skip to main content
OpenTrials
Completed

NCT Number: NCT04716920

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

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.

Completed

Looking for future studies?

Notify Me

Key information

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

Other

Attend Tai Chi exercise classes

Fitbit

Device

Wear FitBit

Support Group Therapy

Other

Join Tai4Chijoint group

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. Tai Chi practice

    Time frame: Up to 12 weeks

    Diary log form.

  2. Tai Chi practice

    Time frame: Up to 12 weeks

    Examples include documenting potential issues that participants think might be intervention-related.

  3. Assess the client's perspective on the value of services received

    Time frame: Up to 36 weeks

    Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.

  4. Lower-extremity joint symptoms

    Time frame: Up to 12 weeks

    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.

  5. Pain, stiffness, and physical function in the hands

    Time frame: Up to 12 weeks

    Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.

  6. Assess pain, pain severity, and pain interference

    Time frame: up to 12 weeks

    Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.

  7. Fatigue

    Time frame: Up to 12 weeks

    Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.

  8. Effects of Hot Flashes on Quality of life

    Time frame: Up to 12 weeks

    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.

  9. Assessment of Sleep quality

    Time frame: Up to 12 weeks

    Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.

  10. Cancer-related distress

    Time frame: Up to 12 weeks

    Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.