Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia

Официальное название

Evaluating Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Consent Rate [Срок оценки: Up to 6 months]
• Engagement Rate [Срок оценки: 12 weeks]
• Retention Rate [Срок оценки: 20 weeks]

Вторичные конечные точки (2)

• Client Satisfaction Questionnaire Score [Срок оценки: 12 weeks]
• Patient Perceived Credibility of the Intervention [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

-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

Критерии исключения

-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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Идентификаторы

NCT: NCT07737951 · iRIS-ID-2025-0036 · JT 44717

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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