Auricular Point Acupressure to Manage Aromatase Inhibitor Musculoskeletal Symptoms in Postmenopausal Breast Cancer Survivors
追踪信息 | |||
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首次提交日期 ICMJE | October 3, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | June 1, 2019 | ||
预计主要完成日期 | January 1, 2024 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in Pain Intensity as assessed by the Brief Pain Inventory-short form[ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ] The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain. Change in Physical Function as assessed by the Western Ontario and McMaster Osteoarthritis Index[ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ] The Western Ontario and McMaster Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. The WOMAC score range from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Change in Physical disability as assessed by the QuickDASH[ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ] QuickDASH outcome measure is used. At least 10 of the 11 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. The value is then transformed to score out of 100. The score range will be 0 to 100. Higher score indicating greater disability. Change in Physical Strength as assessed by Handgrip[ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ] Handgrip strength is a simple and commonly used test of a person's general strength level. There is a simple norm table which is categorized with age is used to measure the strength. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
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描述性信息 | |||
简略标题 ICMJE | Auricular Point Acupressure to Manage Aromatase Inhibitor Musculoskeletal Symptoms in Postmenopausal Breast Cancer Survivors | ||
正式标题 ICMJE | Auricular Point Acupressure to Manage Aromatase Inhibitor Musculoskeletal Symptoms in Postmenopausal Breast Cancer Survivors | ||
简要概况 | Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care. The investigators propose to test auricular point acupressure- —an innovative, non-invasive, nonpharmacologic, and low-cost intervention- —to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these. This study will identify a novel approach to manage aromatase inhibitor musculoskeletal symptoms in postmenopausal breast cancer survivors, with minimal side effects. If successful, the paradigm of pain management will shift from a traditional medical model to a larger integrative medicine and patient-management paradigm to avoid unnecessary evolution towards prolonged disability. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Factorial Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
288 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | January 1, 2024 | ||
预计主要完成日期 | January 1, 2024 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age - Currently receiving AIs (anastrazole, letrozole, exemestane) per chart documentation for at least 2 months (the peak onset of AIMSS is 1.6 months). - Able to read and write English - Have joint pain attributable to AI—or had pre-existing joint pain that worsened after the initiation of AIs—and had worst joint pain rated as 4 or more on a 0-10 numeric rating scale in the previous week - Are willing to commit to weekly study visits for 4 weeks during the intervention and monthly follow-up visits for 3 months (up to 4 months) - Able to apply pressure to the seeds taped to the ears Exclusion Criteria: - Metastatic breast cancer - Completed cytotoxic chemotherapy or radiation therapy less than 4 weeks prior to enrollment (because chemotherapy and radiation therapy can cause temporary exacerbation of joint symptoms that typically resolve spontaneously) - Bone fracture/surgery of an affiliated extremity during the preceding 6 months - Current use of corticosteroids or narcotics - Ear skin disease - Allergy to the tape used for this study - Having had previous auricular therapy (because they would be unable to be blinded for the study) - Having been hospitalized for mental health reasons within the last 3 months - Piercings on the ear points for treatment | ||
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年龄 | 最小年龄:N/A ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
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管理信息 | 数据检测委员会 | ||
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Johns Hopkins University | ||
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验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |