The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center
研究概览
简要总结
The goal of this research study is to learn if a type of light therapy can be used to help patients with advanced cancer who are having difficulty sleeping to sleep better.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to one of two groups:
- Group 1 will receive one type of light therapy for 30 minutes every day for 14 days.
- Group 2 will receive a placebo light for 30 minutes every day for 14 days. The placebo light is not designed to have any effect on your sleep.
You will not know which group you are in. After 14 days, both groups will begin receiving the light therapy for another 14 days.
Litebook:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced cancer patients seen in Supportive Care outpatient clinic at M.D. Anderson Cancer Center, with average sleep disturbance >=4 out of 10 for at least one week
- •Age 18 or greater
- •Karnofsky performance status score of >=40 at time of inclusion into study
- •Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits
- •English speaking
排除标准
- •Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
- •Patients with a history of retinal disease
- •Patients with a current diagnosis of major depression disorder or generalized anxiety disorder
- •Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject
- •Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
- •Patients who are currently receiving ultraviolet A light/ultraviolet B light (UVA/UVB) therapy or tanning sessions at salons
- •Patients with a diagnosis of obstructive sleep apnea or narcolepsy
- •Patients with >2 hours of direct exposure to outdoor natural light per day (light exposure diary -- screening).
研究组 & 干预措施
Bright Light Therapy
Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
干预措施: Study Diaries (Behavioral)
Bright Light Therapy
Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
干预措施: Bright Light Therapy (Other)
Bright Light Therapy
Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
干预措施: Questionnaires (Behavioral)
Bright Light Therapy
Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
干预措施: Bright Light Litebook (Device)
Dim Red Light Therapy
Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
干预措施: Dim Red Light Therapy (Other)
Dim Red Light Therapy
Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
干预措施: Questionnaires (Behavioral)
Dim Red Light Therapy
Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
干预措施: Study Diaries (Behavioral)
Dim Red Light Therapy
Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
干预措施: Red Light Litebook (Device)
结局指标
主要结局
Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center
时间窗: Baseline and Day 14
Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance.
次要结局
未报告次要终点