A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in fatigue symptoms from baseline to post-treatment
研究概览
简要总结
Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.
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
- Double (Participant, Investigator)
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
- •English speaking
- •Non metastatic cancer
- •At least 3 months post chemotherapy/radiation treatment (hormone treatment ok)
- •Meets criteria for cancer-related fatigue
排除标准
- •Under 18 years of age
- •Presence of a sleep disorder other than insomnia or hypersomnia
- •Shift work
- •Presence of an Axis-I psychiatric condition
- •Presence of a medical condition that may impact levels of fatigue
- •Presence of conditions contraindicated to the use of light therapy or photosensitizing medications
- •Randomization refusal
研究组 & 干预措施
Bright White Light
Bright white light exposure every morning for 30 minutes for 28 consecutive days
干预措施: Bright white light (Device)
Dim Red Light
Dim red light exposure every morning for 30 minutes for 28 consecutive days
干预措施: Dim red light (Device)
结局指标
主要结局
Change in fatigue symptoms from baseline to post-treatment
时间窗: Baseline, after each treatment week (each week for 4 weeks), and at week 5
次要结局
- Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment(Baseline (for 7 days), week 5 (for 7 days))
- Change in subjective measures of sleep using sleep diaries from baseline to post-treatment(Baseline (for 7 days), week 5 (for 7 days))
- Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment(Baseline, week 5)
- Change in Profile of Mood States scores from baseline to post-treatment(Baseline, week 5)
- Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment(Baseline, week 5)
- Change in salivary cortisol from baseline to post-treatment(Baseline (for 3 days), week 5 (for 3 days))
- Change in inflammatory cytokines from baseline to post-treatment(Baseline, week 5)
- Change in Insomnia Severity Index scores from baseline to post-treatment(Baseline, week 3, week 5)
研究者
Tavis S. Campbell
Dr. Tavis S. Campbell
University of Calgary