Acupuncture for Sleep Disruption in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Fatigue reduction
研究概览
简要总结
The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Females diagnosed with breast cancer who are not currently undergoing cancer treatment (hormonal treatment is permitted).
- •The last cancer treatment ≥ 2 weeks prior to screening.
- •≥ 21 years of age.
- •Able to understand written and spoken English.
- •Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11 am.
- •Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview of Sleep Disorders) with duration ≥ 1 month by Screening.
- •Willingness to discontinue the use of any current sleep aides (prescription, OTC, or naturopathic agents).
- •Properly executed Informed Consent.
- •Karnofsky Performance Scale Index score ≥ to 70, (patients who score between 61-69 might be included per PI's evaluation).
- •Insomnia Severity Index (ISI) > 8 at Screening.
- •Able to travel to Stanford University and vicinity for assessments and acupuncture treatments.
排除标准
- •Unstable medical or psychiatric illness (eMINI, current or within the last 5 years).
- •Exposure to acupuncture within 6 months prior to screening.
- •Currently pregnant or nursing.
- •History of substance abuse or meet criteria for current alcohol abuse or dependence.
- •Center for Epidemiological Studies Depression Scale (CES-D) >27 at Screening. Meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is ≥ to
- •Major surgery within 4 weeks prior to first acupuncture treatment.
结局指标
主要结局
Fatigue reduction
时间窗: 1 month and 3 months post final acupuncture treatment
Insomnia reduction
时间窗: 1 month and 3 months post final acupuncture treatment
Quality of life in breast cancer survivors after acupuncture
时间窗: 1 month and 6 months post final acupuncture treatment
Quality of life in breast cancer survivors after acupuncture will be measured through questionnaire using 28 item scale of functional assessment of chronic illness therapy- fatigue subscale (FACIT-F) version 4. Total score ranges from 0 to 108. A higher score indicates better quality of life.
次要结局
未报告次要终点
研究者
David Spiegel
Jack, Samuel and Lulu Willson Professor in Medicine
Stanford University