NCT00440089已完成2 期
Effects of Hands-on-Healing vs. Touch for Fatigue and Inflammation in Breast Cancer Survivors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Multiple Fatigue Symptom Inventory
研究概览
简要总结
This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors. Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.
详细描述
Please see our website at http://healing.ucsd.edu for detailed information on the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal and postmenopausal women between the ages of 18 to 70 years.
- •Ability to give informed consent.
- •Breast cancer survivors who have undergone surgery, including lumpectomy and simple or total mastectomy, followed by chemotherapy or a combination of chemo- and radio-therapy. We have elected to study survivors instead of patients actively undergoing treatment to alleviate subject burden and risk during this protocol.
- •Stage I to III breast cancer survivors.
- •Breast cancer survivors who have finished their chemotherapy and/or radiotherapy at least one month prior to 60 months prior.
- •Breast cancer survivors with above-normative levels of fatigue.
排除标准
- •Breast cancer patients who are currently receiving or who are scheduled to receive radiation or chemotherapy during the course of this intervention study.
- •Patients with current major depression, current or history of prior bipolar illness, currently on psychotropic medications.
- •Patients with other diseases that are known to induce fatigue (e.g., thyroid disorder; sleep disorders).
- •Patients with other inflammatory diseases that affect cytokine levels.
- •Patients with a history of other cancers, and stage IV breast cancer.
- •Patients undergoing current chemotherapy and/or radiotherapy.
- •Men with breast cancer.
- •Substance abuse/dependence.
- •Continued use of another biofield-based intervention (e.g., Reiki, Qi-Gong, Healing Touch, Therapeutic Touch, Johrei).
结局指标
主要结局
Multiple Fatigue Symptom Inventory
次要结局
- Inflammatory Immune Markers
- Diurnal Cortisol Variability
研究者
研究点 (4)
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