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

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ClinicalTrials.gov Identifier: NCT04716920
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Other: Tai Chi Device: FitBit Other: Support Group Therapy Other: Questionnaire Administration Other: Quality-of-Life Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients
Actual Study Start Date : March 11, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)
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 Chi
Attend Tai Chi exercise classes

Device: FitBit
Wear FitBit

Other: Support Group Therapy
Join Tai4Chijoint group

Other: Questionnaire Administration
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716920


Contacts
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Contact: Kuang-Yi Wen 215-503-4623 Kuang-Yi.Wen@Jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Cancer Institute (NCI)
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04716920    
Other Study ID Numbers: 20G.093
NCI-2020-02555 ( Other Identifier: The Buck Foundation )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations