Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- PROMIS Pain Interference
研究概览
简要总结
The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.
详细描述
The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with histologically confirmed stage 0, I, II, or III breast cancer
- •who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
- •are currently receiving adjuvant endocrine therapy
- •are able to read and speak English
- •with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms
排除标准
- •have self-reported hospitalization for psychiatric illness within the past 2 years
- •have a bleeding disorder
- •physically or cognitively unable to complete the study procedures
- •pregnant women
结局指标
主要结局
PROMIS Pain Interference
时间窗: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
PROMIS Fatigue
时间窗: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that severe fatigue
PROMIS Sleep Disturbance
时间窗: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Scores range from 4-20; higher scores indicate that severe sleep disturbance
次要结局
- PROMIS Depression(After 10th acupuncture treatment, at 6 weeks post-baseline (study completion))
- PROMIS Anxiety(After 10th acupuncture treatment, at 6 weeks post-baseline (study completion))
研究者
Hongjin Li
Assistant Professor
University of Illinois at Chicago