Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients
| Verified date | September 2022 |
| Source | Thomas Jefferson University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | December 23, 2021 |
| Est. primary completion date | July 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Be able to speak and read English - Been diagnosed with stage I-III breast cancer (BC) - Had completed all active treatments - Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months - Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI - Report worst pain in the past week >= 4 on a 0-10 numeric rating scale - Be willing to adhere to all study procedures Exclusion Criteria: - Has been diagnosed with another form of cancer in the past 5 years - Uncontrolled cardiac, pulmonary, or infectious disease - Body mass index (BMI) > 40 kg/m^2 - Currently attending any mind-body therapy classes (e.g. yoga) - Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data) - Had surgery or joint infection in the past 6 months - Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months |
| Country | Name | City | State |
|---|---|---|---|
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Thomas Jefferson University | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tai Chi practice | Diary log form. | Up to 12 weeks | |
| Primary | Tai Chi practice | Examples include documenting potential issues that participants think might be intervention-related. | Up to 12 weeks | |
| Primary | Assess the client's perspective on the value of services received | Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview. | Up to 36 weeks | |
| Primary | Lower-extremity joint symptoms | Western Ontario and McMaster Universities Arthritis Index will be used to assess pain in the past 7 days in three domains: pain, stiffness, and physical function; higher scores indicating worse pain, stiffness, and functional limitations. | Up to 12 weeks | |
| Primary | Pain, stiffness, and physical function in the hands | Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands. | Up to 12 weeks | |
| Primary | Assess pain, pain severity, and pain interference | Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week. | up to 12 weeks | |
| Primary | Fatigue | Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency. | Up to 12 weeks | |
| Primary | Effects of Hot Flashes on Quality of life | Hot Flash Related Daily Interference Scale will be used to measure the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life. | Up to 12 weeks | |
| Primary | Assessment of Sleep quality | Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month. | Up to 12 weeks | |
| Primary | Cancer-related distress | Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms. | Up to 12 weeks |
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