Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Postmenopausal
Conditions
Keywords
Anatrozole, Letrozole, Exemestane, Tai Chi
Brief 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. 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.
Interventions
BEHAVIORALTai Chi
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.
BEHAVIORALHealth Education
Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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 * 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
Exclusion criteria
-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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent Rate | Up to 6 months | Percentage of eligible participants who consent and enroll in the study. |
| Engagement Rate | 12 weeks | Percentage of intervention sessions attended by enrolled participants. |
| Retention Rate | 20 weeks | Percentage of participants completing study follow up assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire Score | 12 weeks | 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. |
| Patient Perceived Credibility of the Intervention | 12 weeks | 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. |
Countries
United States
Contacts
CONTACTKuang-Yi Wen, PhD
PRINCIPAL_INVESTIGATORKuang-Yi Wen, PhD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Outcome results
None listed