Hormone Receptor Positive Breast CarcinomaNCT07737951
Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia
A study testing Tai Chi and Health Education in people with Hormone Receptor Positive Breast Carcinoma and Postmenopausal, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The objective of the pilot RCT is to evaluate the feasibility and acceptability of a Tai Chi intervention "TaiChi4Joint" vs. an HE AC group for relieving AIIA in women with hormone receptor positive stage I-III BCa. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Breast Carcinoma, Postmenopausal, Breast Cancer
- What is being tested?
- Tai Chi and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- Age ≥18 years
- Diagnosis of stage I-III hormone receptor-positive breast cancer
- Postmenopausal
- Currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation
- Report joint pain that started or worsened after initiation of AI therapy
Show all 9Show fewer
- Report worst pain in the past week ≥3 on the BPI (0-10 scale)
- Able to complete study procedures in English
- Willing to be randomized to an intervention or attention control group and adhere to study procedures
Who cannot join
- -An individual who meets any of the following criteria will be excluded from participation in this study:
- Undergoing active cancer treatment (excluding endocrine therapy)
- Uncontrolled cardiac or pulmonary disease that would limit safe participation
- Currently engaged in regular structured moderate- or vigorous-intensity exercise (e.g., brisk walking, jogging/running, cycling, swimming, aerobic classes, or resistance training) totaling ≥150 minutes per week over the past 3 months
- Currently participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months
- Joint pain due to inflammatory arthritic conditions
Show all 10Show fewer
- Recent surgery or joint injection within the past 4-6 weeks
- Initiation or dose change of corticosteroids or opioids within the past 4 weeks
- Planned discontinuation of AI therapy within the next 6 months
- This study is limited to women with breast cancer, as <1% of cases occur in men and data on AIIA in male patients are limited
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kuang-Yi Wen, MD, 2155034623, Kuang-Yi.Wen@Jefferson.edu
About this study
Official title: Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
The objective of the pilot RCT is to evaluate the feasibility and acceptability of a Tai Chi intervention "TaiChi4Joint" vs. an HE AC group for relieving AIIA in women with hormone receptor positive stage I-III BCa. The investigators will pilot test our data collection for mechanism measures via three innovatively integrated biobehavioral pathways.
Read the detailed description
40 patients from Thomas Jefferson University with a diagnosis of stage I-III hormone receptor-positive breast cancer who are postmenopausal, currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation, report joint pain that started or worsened after initiation of AI therapy, and report worst pain in the past week of ≥3 on the Brief Pain Inventory (BPI) 0-10 scale, indicating at least moderate pain. Eligible participants must be able to complete study procedures in English, be willing to be randomized in a 1:1 ratio to the intervention or attention control group, and adhere to study procedures. Participants will be excluded if they are currently engaged in regular structured moderate- or vigorous-intensity exercise totaling ≥150 minutes per week over the past 3 months, or participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months.
BCa patients with AIIA during the first 2 years of AI initiation will be equally randomized to either the TaiChi4Joint group or a health education AC group for 12 weeks.
TaiChi4Joint Group: Routine virtual Tai Chi group classes via Zoom for 1 hour, twice a week, for 12 weeks, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow-up. Health Education Attention Control Group: Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
Primary Objectives: Examine the feasibility and acceptability of the RCT design and implementation Feasibility will be measured through consent rate, treatment attendance and retention.
Secondary Objectives: Examine the acceptability of the interventions. Acceptability will be indicated by participants-reporting treatment satisfaction using a standardized measure. Patient perceived creditability of the intervention, and patients' fidelity of the intervention and teleassessment will also be measured.
- Being tested
- Tai Chi, Health Education
- Keywords
- Anatrozole, Letrozole, Exemestane, Tai Chi
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Also called TaiChi4Joint
Routine virtual Tai Chi group classes via Zoom for 1 hour, twice a week, for 12 weeks, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow-up.
Health EducationBehavioural
Also called Health Education Attention Control Group
Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
| Study group | Role | What they receive |
|---|---|---|
| TaiChi4Joint | Experimental | Participants randomized to the TaiChi4Joint group will attend virtual Tai Chi classes via Zoom (1 hour, twice weekly for 12 weeks). At the first class, participants will review a Tai Chi safety and modifications handout. Using a manualized approach, each session includes structured objectives and activities to progressively learn simplified Tai Chi forms, with weekly verification of skill attainment. Six core elements are emphasized: (1) mindfulness (present-focused attention); (2) postural alignment (efficient, upright movement); (3) natural breathing (integrated with movement); (4) active relaxation (remaining relaxed while moving); (5) slow movement (building strength and endurance); and (6) integrated movement (coordinating functional movements). Receives: Behavioral: Tai Chi |
| Health Education Attention Control | Active comparator | To control for the attention that the TaiChi4Joint group receives, women randomized to the AC group will participate Routine virtual AC group classes via Zoom or via video link for 1 hour, twice a week, for 12 weeks, including survivorship content or healthy eating.
The AC group is designed to control for attention and for expectations about getting some benefits from the treatment. The AC group is controlled for time and will also be 1 hour each time, twice a week, matching the frequencies and intensity of the intervention group. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
Percentage of eligible participants who consent and enroll in the study.
Measured: Up to 6 months
Engagement Rate
Percentage of intervention sessions attended by enrolled participants.
Measured: 12 weeks
Retention Rate
Percentage of participants completing study follow up assessments.
Measured: 20 weeks
Secondary outcomes (2)
Client Satisfaction Questionnaire Score
Participant reported satisfaction with the intervention measured using the Client Satisfaction Questionnaire. Acceptability will be 1) 80% of participants report a mean score of 4 or higher on participants' responses to study acceptability items on the Client Satisfaction Questionnaire. Client Satisfaction Questionnaire - 8 Item Version (CSQ-8) is a standardized measure of global satisfaction with services. It consists of 8 items, each rated on a 4-point Likert scale, with responses summed to yield a total score ranging from 8 (minimum) to 32 (maximum). Higher scores indicate a better outcome, reflecting greater client satisfaction with the services received.
Measured: 12 weeks
Patient Perceived Credibility of the Intervention
Primary benchmark for Credibility will be 2) a mean score of 4 or higher on participants 'responses to study items from the Credibility/Expectancy Questionnaire. 3) Chi-square tests will compare feasibility metrics by White vs. AA patients. Quantitative acceptability ratings will be summarized. The Credibility/Expectancy Questionnaire (CEQ) is a measure of treatment credibility and expectancy for improvement. It includes a Credibility subscale (3 items scored on a 1-9 scale) with total scores ranging from 3 (minimum) to 27 (maximum), and an Expectancy subscale (2 items scored on a 0-100 scale) with scores typically averaged to yield a range from 0 (minimum) to 100 (maximum). For both subscales, higher scores indicate a better outcome, reflecting greater perceived credibility of the intervention and stronger expectations that the treatment will be effective.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start27 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Yi Wen, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737951
- Sponsor's protocol ID
- iRIS-ID-2025-0036
- Other IDs
- JT 44717
- Status last verified
- Aug 2026
- First submitted
- 20 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07737951
- Acronym / sponsor ID
- iRIS-ID-2025-0036
- Keywords
- Anatrozole, Letrozole, Exemestane, Tai Chi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the pilot RCT is to evaluate the feasibility and acceptability of a Tai Chi intervention "TaiChi4Joint" vs. an HE AC group for relieving AIIA in women with hormone receptor positive stage I-III BCa. The investigators will pilot test our data collection for mechanism measures via three innovatively integrated biobehavioral pathways.
Detailed description
40 patients from Thomas Jefferson University with a diagnosis of stage I-III hormone receptor-positive breast cancer who are postmenopausal, currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation, report joint pain that started or worsened after initiation of AI therapy, and report worst pain in the past week of ≥3 on the Brief Pain Inventory (BPI) 0-10 scale, indicating at least moderate pain. Eligible participants must be able to complete study procedures in English, be willing to be randomized in a 1:1 ratio to the intervention or attention control group, and adhere to study procedures. Participants will be excluded if they are currently engaged in regular structured moderate- or vigorous-intensity exercise totaling ≥150 minutes per week over the past 3 months, or participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months.
BCa patients with AIIA during the first 2 years of AI initiation will be equally randomized to either the TaiChi4Joint group or a health education AC group for 12 weeks.
TaiChi4Joint Group: Routine virtual Tai Chi group classes via Zoom for 1 hour, twice a week, for 12 weeks, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow-up. Health Education Attention Control Group: Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
Primary Objectives: Examine the feasibility and acceptability of the RCT design and implementation Feasibility will be measured through consent rate, treatment attendance and retention.
Secondary Objectives: Examine the acceptability of the interventions. Acceptability will be indicated by participants-reporting treatment satisfaction using a standardized measure. Patient perceived creditability of the intervention, and patients' fidelity of the intervention and teleassessment will also be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaiChi4Joint | Experimental | Behavioral: Tai ChiParticipants randomized to the TaiChi4Joint group will attend virtual Tai Chi classes via Zoom (1 hour, twice weekly for 12 weeks). At the first class, participants will review a Tai Chi safety and modifications handout. Using a manualized approach, each session includes structured objectives and activities to progressively learn simplified Tai Chi forms, with weekly verification of skill attainment. Six core elements are emphasized: (1) mindfulness (present-focused attention); (2) postural alignment (efficient, upright movement); (3) natural breathing (integrated with movement); (4) active relaxation (remaining relaxed while moving); (5) slow movement (building strength and endurance); and (6) integrated movement (coordinating functional movements). |
| Health Education Attention Control | Active comparator | Behavioral: Health EducationTo control for the attention that the TaiChi4Joint group receives, women randomized to the AC group will participate Routine virtual AC group classes via Zoom or via video link for 1 hour, twice a week, for 12 weeks, including survivorship content or healthy eating. The AC group is designed to control for attention and for expectations about getting some benefits from the treatment. The AC group is controlled for time and will also be 1 hour each time, twice a week, matching the frequencies and intensity of the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- Age ≥18 years
- Diagnosis of stage I-III hormone receptor-positive breast cancer
- Postmenopausal
- Currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation
Key exclusion criteria (10 listed)
- -An individual who meets any of the following criteria will be excluded from participation in this study:
- Undergoing active cancer treatment (excluding endocrine therapy)
- Uncontrolled cardiac or pulmonary disease that would limit safe participation
- Currently engaged in regular structured moderate- or vigorous-intensity exercise (e.g., brisk walking, jogging/running, cycling, swimming, aerobic classes, or resistance training) totaling ≥150 minutes per week over the past 3 months
- Currently participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiAlso: TaiChi4JointRoutine virtual Tai Chi group classes via Zoom for 1 hour, twice a week, for 12 weeks, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow-up. | Behavioural | TaiChi4Joint |
| Health EducationAlso: Health Education Attention Control GroupRoutine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up. | Behavioural | Health Education Attention Control |
Primary outcome
Consent Rate
Time frame: Up to 6 months
Percentage of eligible participants who consent and enroll in the study.
Engagement Rate
Time frame: 12 weeks
Percentage of intervention sessions attended by enrolled participants.
Retention Rate
Time frame: 20 weeks
Percentage of participants completing study follow up assessments.
2 secondary outcomes
Client Satisfaction Questionnaire Score
Time frame: 12 weeks
Patient Perceived Credibility of the Intervention
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kuang-Yi Wen, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Health Education in people with Hormone Receptor Positive Breast Carcinoma and Postmenopausal, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Yi Wen, PhD (215-503-4623, Kuang-Yi.Wen@Jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.