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Estrogen receptor–positive breast cancer is the most common type of breast cancer in postmenopausal women. Aromatase inhibitors (AIs) are the endocrine therapy of choice recommended for these patients. Up to 50% of those treated with an AI develop arthralgia, often resulting in poor adherence and decreased quality of life.
The study is a single-arm longitudinal pilot study aiming to evaluate the safety, feasibility, acceptability, and potential efficacy of
Women diagnosed with stage 0-III breast cancer who received an AI for at least 2 months and reported arthralgia with a ≥4 score on a 0 to 10 scale for joint pain were eligible for study enrollment. Participants were encouraged to join tai chi classes delivered over Zoom three times a week for 12 weeks. Program engagement strategies included using a private Facebook study group and a Box cloud for archiving live class recordings. The program uses SMS text messaging and emails with periodic positive quotes and evidence-based information on tai chi for facilitating community bonding and class attendance. Participants were invited to complete the following assessments at baseline and at 1-, 2-, and 3-month intervals from study enrollment: Brief Pain Inventory, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), The Australian Canadian Osteoarthritis Hand Index (AUSCAN), Fatigue Symptom Inventory, Hot Flash Related Daily Interference Scale (HFRDIS), Pittsburgh Sleep Quality Index (PSQI), and Center for Epidemiological Studies–Depression (CES-D).
A total of 55 eligible patients were invited to participate, and 39 (71%) consented and completed the baseline assessments. Participants attended 61% (median) of the suggested classes, with no tai chi–related adverse events reported. Of the 39 participants, 22 completed the 3-month follow-up assessment with a 56% retention rate. Study participants reported improvement from baseline compared to 3 months as follows (paired
The COVID-19 global pandemic has resulted in the need to rethink how mind-body therapies can be delivered. This study demonstrated the feasibility, acceptability, and potential efficacy of a telehealth-based tai chi intervention for reducing AI-induced arthralgia. The intervention decreased patient-reported pain and stiffness, and improved sleep quality and depressive symptoms. Fully powered, large, telehealth-based tai chi trials for AI-associated arthralgia are needed considering our promising findings.
ClinicalTrials.gov NCT04716920; https://www.clinicaltrials.gov/ct2/show/NCT04716920
Breast cancer (BC) is the most common cancer among women in the United States, and hormone receptor–positive BC accounts for approximately two-thirds of all BC. For postmenopausal women with hormone receptor–positive BC [
The approach to managing AI-related arthralgia is complex due to the absence of validated treatment standards for clinicians to use. They are complicated by limited knowledge regarding the physiological mechanisms involved. Unfortunately, pharmacological interventions to treat AI-related arthralgia have resulted in limited relief [
Tai chi is a multidimensional mind-body therapy that integrates moderate physical activity, deep breathing, and meditation; additionally, it offers a promising approach to symptom management in cancer populations [
Furthermore, tai chi interventions designed specifically for individuals with pain-related conditions (eg, osteoarthritic knee pain) have significantly improved pain and physical functional outcomes [
Inclusion criteria for study participation included participants being ≥18 years of age, being able to speak/read English, having been diagnosed with stage 0-III BC, being postmenopausal (ie, no menses for at least 1 year), receiving an AI (anastrozole, letrozole, or exemestane) for at least 2 months, having joint pain that started or worsened after the initiation of AIs, reporting that their worst pain score in the prior week was ≥4 score on a 0 to 10 scale, and willing to adhere to all the study procedures.
Exclusion criteria included having another type of cancer that was diagnosed in the past 5 years; having uncontrolled cardiac, pulmonary, or infectious disease; having a BMI>40 kg/m2; currently attending any mind-body therapy classes (eg, tai chi or yoga); having joint pain due to an inflammatory arthritic condition; having surgery in the past 6 months; having a joint injection in the past 3 months; currently taking corticosteroids or opioids; or having discontinued or planning to discontinue their AI in the next 6 months.
A research team member screened potentially eligible patients via the electronic medical record or were referred by the patient’s treating medical oncologists. The study team connected with major support groups in the greater Philadelphia area to promote the study and potentially reach eligible participants. An informed consent form was signed, mailed, and returned by a study participant after reviewing the study rationale, intervention, and potential adverse effects with a research team member. The research team also provided remote assistance over the phone to ensure that the Zoom platform was successfully installed on the participant’s computer, tablet, or smartphone and that they could access classes on time. Participants were instructed to complete baseline, 1-month, 2-month, and 3-month surveys either by a mailed paper-based survey or via a REDCap online survey.
This study with IRB control number 20G.093 was administratively approved by Thomas Jefferson University Institutional Review Board on January 30, 2020 by Board number 2405. Study accrual began in December 2020 and was completed in April 2021.
Tai chi is a multicomponent practice that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. Participants were invited to attend three tai chi classes per week for the 12-week study duration via the Zoom platform. Using a manualized approach, each class provided objectives and learning activities. The learning activities included sequentially learning a specific set of tai chi that included 24 movements with verification of skills attainment on a weekly basis. Each class began with relaxation exercises that had breathing exercises and qigong warm-ups. The instructor reviewed the previously learned techniques and introduced new movements following the relaxation session. The first 8 weeks of classes focused on mastery of single forms through multiple repetitions. The latter weeks emphasized consolidation of daily practice routines with natural breathing integrated into all classes. Scheduled classes ran from 45 to 60 minutes each and occurred 4 times per week, thus allowing patients to choose 3 classes that best fit their schedule. Participants were also encouraged to practice these tai chi classes through video recordings and spend 30 minutes daily on most days of the week self-practicing the technique they learned.
Participants were encouraged to join an optional Facebook private
We collected the following study subject demographics and BC-specific information: age, race, ethnicity, education, marital status, BC diagnosis and stage, treatment history, and AI medication type.
We aimed to retain 50% of eligible patients at the 3-month follow-up survey. The cutoff of 50% retention rate was chosen and derived from other similar pilot studies using mind-body therapies to mitigate arthralgia [
The acceptability of the study intervention was defined as a 60% consenting rate. Justification for a 60% consenting rate as acceptable was based on prior BC survivorship behavioral studies [
As arthralgia primarily affects the hips and knees [
We used the Australian Canadian Osteoarthritis Hand Index (AUSCAN) to assess pain and physical function in the hands. AUSCAN has been reported to have excellent sensitivity and responsiveness in detecting and measuring AI-induced arthralgia [
The Brief Pain Inventory (BPI) is a 14-item questionnaire developed for use in patients with cancer that assesses the worst pain, pain severity, and pain interference over the past week reported on a scale of 0 to 10. The BPI is the most common, valid, and reliable measure to assess pain in patients with cancer.
The Fatigue Symptom Inventory (FSI) measure is a 13-item self-report measure shown to be sensitive to assessing change in fatigue among patients with BC and with substantial internal consistency. An overall score was used.
We used the Hot Flash Related Daily Interference Scale (HFRDIS) to measure the effect of hot flashes on the overall quality of life and nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life [
We used the Pittsburgh Sleep Quality Index (PSQI) for a subjective sleep assessment, including multiple sleep-related variables over the preceding month [
We used the Center for Epidemiological Studies–Depression (CES-D) to assess depressive symptoms [
The statistical analysis was performed using R (R Foundation for Statistical Computing). Summary demographic statistics were calculated. Summary statistics of the end points, WOMAC subscales, AUSCAN subscales, BPI, FSI, HFRDIS, PSQI, and CES-D at baseline and at 1-month, 2-month, and 3-month follow-ups were calculated. Paired
The mean age of patients was 58 (SD 10.6) years. Of the 39 patients, 30 were Caucasian and 36 were at least college graduates. There were 31 patients with stage I or II, and had undergone mastectomy (n=22), radiation (n=27), or chemotherapy (n=23). Half of the participants (n=21) had been taking anastrozole. A total of 24 patients had been taking an AI for less than 3 years (
Participant characteristics.
Variable | Participants (N=39) | ||
Age (years), mean (SD) | 58.18 (10.60) | ||
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Caucasian | 30 (77) | |
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African American | 7 (18) | |
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Asian | 1 (3) | |
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Unreported | 1 (3) | |
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Non-Hispanic | 38 (97) | |
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Hispanic | 1 (3) | |
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Married | 26 (67) | |
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Single | 7 (18) | |
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Divorced | 5 (13) | |
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Widowed | 1 (3) | |
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High school | 3 (8) | |
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College graduate | 16 (41) | |
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Postgraduate school | 20 (51) | |
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0 | 2 (5) | |
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I | 14 (36) | |
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II | 17 (44) | |
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III | 6 (15) | |
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Mastectomy | 22 (56) | |
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Lumpectomy | 15 (39) | |
Radiationa, n (%) | 27 (69) | ||
Chemotherapya, n (%) | 23 (59) | ||
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Letrozole | 6 (15) | |
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Anastrozole | 21 (54) | |
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Exemestane | 9 (23) | |
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Other | 3 (8) | |
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≤1 | 12 (31) | |
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1-3 | 12 (31) | |
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3-6 | 12 (31) | |
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Unreported | 3 (8) |
aTreatment options do not add up to 39 due to individual treatment choices.
bAI: aromatase inhibitor.
A total of 55 eligible patients were invited to participate, and 39 of the 55 (70.9%, 95% exact CI 57.1%-82.4%) patients consented to study participation and completed the baseline assessment, which exceeded the acceptability threshold of 60%. To seek participants’ feedback on the intervention, 14 of 22 participants who completed the final survey responded to our postintervention evaluation. All 14 perceived high satisfaction with the intervention, and 10 reported that the intervention was beneficial in relieving their pain.
Of the 39 participants, 26 completed a 1-month follow-up, 21 completed a 2-month follow-up, and 22 completed the final 3-month follow-up, with a retention rate of 56% (95% exact CI 39.6%-72.2%) at the end of the study. Study attendance was calculated as the number of classes of the 36 suggested classes (12 weeks × 3 per week) each participant attended, ranging from 3% (2 classes) to 100% (36 classes), with a median value of 61% (22 classes). Of the 39 participants, 16 attended 18 (50%) or more classes during the 12-week study period.
Change in patient-reported outcomes over time.
Measure (range) | Baseline (N=39), mean (SD) | 1 month (n=25), mean (SD) | 2 months (n=22), mean (SD) | 3 months (n=21), mean (SD) | 3-month change (95% CI)a | Linear time trend detected by the latent class model | ||
WOMACb pain (0-20 maximal pain) | 8.05 (4.19) | 6.52 (3.70) | 6.36 (4.82) | 5.05 (3.89) | 2.57 (1.27-3.87) | <.001c | –0.51 | <.001c |
WOMAC stiffness (0-8 maximal stiffness) | 4.36 (1.74) | 3.44 (1.61) | 3.00 (1.75) | 2.33 (1.65) | 1.67 (0.81-2.52) | <.001c | –0.77 | <.001c |
WOMAC function (0-68 minimal function) | 23.28 (14.21) | 17.76 (12.36) | 16.32 (13.81) | 11.67 (12.70) | 8.95 (5.65-12.25) | <.001c | –0.71 | <.001c |
BPId (0-10 worse pain) | 5.04 (2.17) | 4.22 (2.29) | 4.16 (1.82) | 2.69 (2.18) | 2.25 (1.27-3.24) | <.001 | –0.456 | <.001 |
AUSCANe pain (0-50 worse pain) | 6.64 (4.57) | 6.00 (4.27) | 4.77 (4.08) | 3.52 (3.56) | 2.33 (0.71-3.96) | .007 | –0.642 | <.001 |
AUSCAN function (0-90 minimal function) | 11.13 (7.63) | 8.80 (8.10) | 7.45 (7.97) | 5.71 (7.27) | 4.48 (1.62-7.33) | .004 | –0.794 | <.001 |
FSIf (0-130 worse fatigue) | 53.40 (27.29) | 40.04 (26.53) | 36.94 (22.02) | 29.74 (20.05) | 17.53 (6.20-28.86) | .004 | –0.61 | <.001 |
HFRDISg (0-100 worse hot flash) | 28.14 (25.46) | 19.27 (22.89) | 13.10 (14.25) | 12.44 (13.78) | 10.15 (2.04-18.26) | .02 | For 28 patients: –0.176; for 11 patients: –1.235 | For 28 patients: .14; for 11 patients: <.001 |
PSQIh (0-21 lower sleep quality) | 18.00 (5.86) | 15.04 (6.52) | 14.55 (5.70) | 11.10 (6.40) | 6.14 (3.32-8.96) | <.001 | –0.626 | <.001 |
CES-Di (0-60 greater depressive symptom severity) | 38.33 (5.61) | 37.40 (4.53) | 36.05 (4.46) | 33.95 (4.97) | 2.62 (0.26-4.97) | .03 | –0.353 | <.001 |
aPaired
bWOMAC: Western Ontario and McMaster University Osteoarthritis Index.
cAdjusted for multiple comparison.
dBPI: Brief Pain Inventory.
eAUSCAN: Australian Canadian Osteoarthritis Hand Index.
fFSI: Fatigue Symptom Inventory.
gHFRDIS: Hot Flash Related Daily Interference Scale.
hPSQI: Pittsburgh Sleep Quality Index.
iCES-D: Center for Epidemiological Studies-Depression.
Comments and suggestions from participants, the tai chi instructor, and our research team’s observation notes were qualitatively summarized and discussed to reach a consensus on each identified theme and areas for future intervention improvement.
Participants reported that their pain or stiffness improved, with the change starting quickly after the first few weeks of the intervention. The reduction in pain also facilitated other improvements in daily activities.
Stiffness and pain decreased. I felt joints in knees and elbows move into my sockets at some point. I’m more limber and able to lift my knees higher to run faster and further.
Within 2 weeks, I had relief from the joint pain, especially my shoulder pain.
Breathing training and exercise were recognized as helpful in improving relaxation and calmness. Many participants also reported their balance was improved over time.
I particularly liked the breathing exercise at the beginning. I will continue to use it for relaxation and mindfulness.
My flexibility and balance have improved.
Our tai chi instructor was perceived as highly supportive and patient. A bonding relationship between the instructor and participants was observed. Archived class videos and motivational words and encouragements delivered in the Facebook private group and SMS text messaging were also reported as positive and helpful, motivating participant’s tai chi practice.
The instructor was amazing and showed extraordinary patience.
It was helpful to have all the classes on the FB page.
I enjoyed the occasional random words of kindness.
Participants commented on the ease and comfort of virtually attending our tai chi classes, overcoming in-person participation barriers such as travel burdens and demanding schedules.
The Zoom class made it easier to fit into my schedule.
I didn’t have to deal with parking.
The main reason for not being able to attend scheduled classes was the participant’s conflicting schedules. Participants reported that their nonattendance generally reflected competing life demands rather than their lack of desire to attend classes. Due to the budget constraint of the pilot, the availability of our weekly offered courses was limited with a fixed schedule of four classes per week.
Would like to have more time options during the week for live classes.
Unfortunately, I have only been able to attend classes twice per week, and several times my schedule prevented me from one of them.
For the pilot, we used rolling enrollment, so participants started the course as they enrolled. However, participants and the instructor observed and reported issues of participants with different levels of tai chi learning progression, reducing the efficiency of the class conduct.
There were beginners starting regularly, so the pace had to remain slow; it was difficult for me to move very slowly when I knew the next move.
We observed a learning curve for using the Zoom technology when participants initially started the intervention. Some of our older participants who joined our Zoom classes using their cellphones experienced viewing difficulties due to the small screen, their vision limitations, and interrupted internet signal. The problem of following the instructor’s side-to-side movements virtually was noted.
Having the class on Zoom presented some challenges initially.
It would have been helpful to have a third camera; it was difficult keeping perspectives –rights and lefts.
AI-induced arthralgia can prohibit normal functioning and decrease affected patients’ quality of life. Clinical trial data show a 22% rate of AI discontinuation due to AI-induced arthralgia [
We also found statistically significant improvements in pain, stiffness, impaired function, fatigue, hot flash, sleep quality, and depressive symptoms. In particular, the change of the WOMAC subscale scores over time, our primary outcome of interest, was clinically meaningful based on prior literature. Qualitative findings, including participants’ perceived reduction in pain and stiffness, improvement in relaxation and balance, and the value of the instructor’s and the intervention’s support, could potentially have facilitated the quantitative change in outcomes observed in the study. Further, to counter potential digital divide challenges and improve participant engagement, the following strategies addressing our lessons learned might be helpful for future studies: include a user manual and training session practicing joining the videoconference, offer loaner iPads with cellular plans, use a multi-camera streaming setup, use closed session groups, and offer a more flexible class schedule. Our results demonstrate the potential of the
This is a single-arm pilot study; this design was the most suitable to tackle the question of feasibility and acceptability. Study outcomes will need more scrutiny under an RCT design with a control group. This will be required to correct for possible selection bias or placebo effects. Selection bias might have been a cause for the study’s favorable results, as patients adhering to the investigation have obtained benefits derived from tai chi practice.
A longer intervention duration and a more extended period of follow-up post intervention might be needed to understand the long-term and maintenance effects of tai chi in reducing AI-induced arthralgia.
The majority of our sample were Caucasian and had a college degree, limiting the generalization of our findings. Innovative recruitment strategies will be needed in the future to ensure the sample is generalizable and to increase outreach and support to minorities.
COVID-19 increased stress levels while reducing access to mind-body services in patients with cancer. Research on remote delivery of integrative, complementary, and alternative medicine health supports the feasibility and benefits of these services [
aromatase inhibitor
Australian Canadian Osteoarthritis Hand Index
breast cancer
Brief Pain Inventory
Center for Epidemiological Studies–Depression
Fatigue Symptom Inventory
Hot Flash Related Daily Interference Scale
Pittsburgh Sleep Quality Index
randomized clinical trial
Western Ontario and McMaster University Osteoarthritis Index
We would like to thank Mr Robert Weiss for his efforts and commitment as a tai chi instructor in our study. We would like to acknowledge Ms Lonaya Baker and Rita Smith for their assistance in recruiting patients. Thanks to Mr Michaël Bijker for providing the soundtrack for the instructional videos. This study was supported by the BUCK Cancer Foundation Medical Research Grant and the Sidney Kimmel Cancer Center Support Grant (National Cancer Institute Award 5P30CA056036-22).
None declared.