Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Effect of bright light on sleep patterns as measured by PSG
研究概览
简要总结
This proposed study will examine feasibility and implement therapeutic bright light that is tailored to the individual's circadian typology to estimate its therapeutic effects on sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •Newly diagnosed with stage I-III breast cancer
- •Scheduled to receive 21-day cycles of intravenous chemotherapy
- •Experiencing disrupted sleep (determined by Pittsburgh Sleep Quality Index)
- •Morning or evening types (determined by Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
- •Mentally competent to consent
- •Able to under English
排除标准
- •Concurrent malignancy
- •Undergoing other cancer treatments
- •Engage in shift work or travel across more than 3 time zones within 2 weeks prior to study
- •Known history of seasonal affective disorder or substance abuse
- •Current diagnosis of major Axis I psychiatric disorders, neurological impairments, or muscular dystrophies
- •Regularly use steroid or other immunosuppressive medications
- •Take prescribed sedative hypnotics or sleep medications because these conditions may affect fatigue and/or sleep/wake patterns.
- •Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g. migraine), or take photosensitizing medications (e.g. some porphyrin drugs, antipsychotics, antiarrhythmic agents)
结局指标
主要结局
Effect of bright light on sleep patterns as measured by PSG
时间窗: Through completion of study (approximately 50 days)
Feasibility of implementing a bright light intervention as measured by estimating completion of scheduled PSG recording
时间窗: Through completion of study (approximately 50 days)
-Feasibility of the procedures will be assessed by descriptive analysis
Effect of bright light on fatigue as measured by VAS (diurnal fatigue) in Daily Fatigue and Sleep Log
时间窗: Through of completion of study (approximately 43 days)
Effect of bright light on sleep patterns as measured by PROMIS-Sleep Disturbance
时间窗: Through of completion of study (approximately 43 days)
Feasibility of implementing a bright light intervention as measured by completion rates of self-report forms
时间窗: Through completion of study (approximately 50 days)
-Feasibility of the procedures will be assessed by descriptive analysis
Effect of bright light on fatigue as measured by PROMIS-Cancer Fatigue
时间窗: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by ESS
时间窗: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by VAS (daytime sleepiness) in Daily Fatigue and Sleep Log
时间窗: Through completion of study (approximately 50 days)
Effect of bight light on sleep patterns as measured by PSQI
时间窗: Through completion of study (approximately 50 days)
Effect of bright light on wake patterns as measured by PSG
时间窗: Through completion of study (approximately 50 days)
Effect of bright light on quality of life as measured by EORCT QLQ C-30
时间窗: Through completion of study (approximately 50 days)
次要结局
未报告次要终点