search
Back to results

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

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
FitBit
Support Group Therapy
Questionnaire Administration
Quality-of-Life Assessment
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tai Chi practice
Diary log form.
Tai Chi practice
Examples include documenting potential issues that participants think might be intervention-related.
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.
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.
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.
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.
Fatigue
Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
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.
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.
Cancer-related distress
Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
September 7, 2022
Sponsor
Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04716920
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
Attend Tai Chi exercise classes
Intervention Type
Device
Intervention Name(s)
FitBit
Intervention Description
Wear FitBit
Intervention Type
Other
Intervention Name(s)
Support Group Therapy
Intervention Description
Join Tai4Chijoint group
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Tai Chi practice
Description
Diary log form.
Time Frame
Up to 12 weeks
Title
Tai Chi practice
Description
Examples include documenting potential issues that participants think might be intervention-related.
Time Frame
Up to 12 weeks
Title
Assess the client's perspective on the value of services received
Description
Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.
Time Frame
Up to 36 weeks
Title
Lower-extremity joint symptoms
Description
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.
Time Frame
Up to 12 weeks
Title
Pain, stiffness, and physical function in the hands
Description
Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.
Time Frame
Up to 12 weeks
Title
Assess pain, pain severity, and pain interference
Description
Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.
Time Frame
up to 12 weeks
Title
Fatigue
Description
Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.
Time Frame
Up to 12 weeks
Title
Effects of Hot Flashes on Quality of life
Description
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.
Time Frame
Up to 12 weeks
Title
Assessment of Sleep quality
Description
Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.
Time Frame
Up to 12 weeks
Title
Cancer-related distress
Description
Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727609
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. Erratum In: JMIR Form Res. 2022 Jul 19;6(7):e40830.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs