Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fatigue as measured by the Brief Fatigue Inventory
研究概览
简要总结
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
详细描述
Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 65 years of age
- •Patient has a rounded Brief Fatigue Inventory score of 4 or greater
- •Patient is in a stable clinical condition
排除标准
- •Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)
- •Karnofsky Performance Status below 70
- •Acupuncture treatment in the previous 6 months
- •Fatigue before cancer diagnosis
- •Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
- •Patient has the potential for serious bleeding due to inherited diseases such as hemophilia
- •Patient is taking medications that are either fatigue-inducing or have sedating properties
- •Patient is unavailable by telephone
结局指标
主要结局
Fatigue as measured by the Brief Fatigue Inventory
时间窗: prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.
次要结局
- Health-Related Quality of Life (HRQoL) as measured by the SF36(prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.)
- Pain as measured by an analog scale(prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.)
- Cognitive complaints as measured by the FACT-COG(prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.)