Health TrialsbyHealthPanel

Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia

ConditionsHormone Receptor Positive Breast CarcinomaPostmenopausalBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tai Chi

    Behavioral

    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

    Behavioral

    Routine virtual AC classes delivered remotely, three assessments: baseline, post-intervention follow-up and 2-month post-intervention follow up.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TaiChi4JointExperimental treatment 1 intervention
Group B: Health Education Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Consent Rate

Percentage of eligible participants who consent and enroll in the study.

Time frame
Up to 6 months
2

Engagement Rate

Percentage of intervention sessions attended by enrolled participants.

Time frame
12 weeks
3

Retention Rate

Percentage of participants completing study follow up assessments.

Time frame
20 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov
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