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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716920
• Other study ID #: 20G.093
• Secondary ID: NCI-2020-02555
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: September 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 23, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Arthralgia
• Breast Neoplasms
• 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

Intervention

Other:
• Tai Chi
Attend Tai Chi exercise classes

Device:
• FitBit
Wear FitBit

Other:
• Support Group Therapy
Join Tai4Chijoint group
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tai Chi practice	Diary log form.	Up to 12 weeks
Primary	Tai Chi practice	Examples include documenting potential issues that participants think might be intervention-related.	Up to 12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cancer-related distress	Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.	Up to 12 weeks