Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors: A Personalized Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Study Attrition and Adherence
研究概览
简要总结
This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.
详细描述
The purpose of this pilot study is to evaluate the feasibility of implementing a home-based, personalized bright light intervention, and to estimate the effects of bright light on 4 common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three specific aims include:
Aim #1: To assess the feasibility of implementing a home-based, personalized bright light intervention and the proposed data collection plan in post-treatment survivors of breast cancer.
Aim #2: To estimate the effects of the personalized bright light intervention on sleep disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of breast cancer.
Aim #3: To estimate the effects of a personalized bright light intervention on circadian rhythms in survivors of breast cancer.
The participants of this randomized, controlled pilot study will be randomized to either 30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light will be self-administered using a light visor cap at home for 14 consecutive days. Tailored to the individual's circadian pattern, light will be delivered either within 30 minutes of waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression, and quality of life will be self-reported; cognition will be objectively assessed before and after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature before and after the intervention. Feasibility will be determined by the proportion of contacted, recruited, and retained subjects, and completeness of the data collected. Subjective feedback and burden will be assessed at study exit.
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
- 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
- 是
入选标准
- •21 years of age or older 1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer
- •Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments)
- •Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41)
- •Mentally competent to consent
- •Able to understand English.
排除标准
- •Undergoing cancer treatment for another malignancy
- •Have metastatic cancer
- •Engaged in shift work or travel across more than three time zones within 2 weeks prior to study
- •Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies
- •Report severe depressive mood (Center for Epidemiological Studies Depression Scale (CES-D) >24)
- •Take prescribed sedative hypnotics or steroids 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
Study Attrition and Adherence
时间窗: Up to 3 weeks from registration
Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention
次要结局
- Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Sleep Disturbance as Measured by the PSQI(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Fatigue as Measured by the Daily Log(Kept throughout the approx 3 weeks of the study)
- Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Depression as Measured by the PROMIS-Depression(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Depression as Measured by the CES-D(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
- Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)(Baseline (day 2 of study) and Post-treatment (approx day 17 of study))
研究者
Horng-Shiuann Wu
Associate Professor
Michigan State University