Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8
- Interventions
- Other: Tai ChiDevice: FitBitOther: Support Group TherapyOther: Questionnaire AdministrationOther: Quality-of-Life Assessment
- Registration Number
- NCT04716920
- Lead Sponsor
- Thomas Jefferson University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group) Support Group Therapy 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. Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group) Quality-of-Life Assessment 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. Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group) Tai Chi 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. Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group) FitBit 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. Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method Tai Chi practice Up to 12 weeks Examples include documenting potential issues that participants think might be intervention-related.
Assess the client's perspective on the value of services received 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.
Assessment of Sleep quality 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.
Cancer-related distress Up to 12 weeks Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.
Assess pain, pain severity, and pain interference up to 12 weeks Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
Fatigue 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.
Lower-extremity joint symptoms 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.
Pain, stiffness, and physical function in the hands Up to 12 weeks Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Effects of Hot Flashes on Quality of life 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States