Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue (PEI)
2020年7月27日 更新者：William H. Redd、Icahn School of Medicine at Mount Sinai
Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the weeks to months prior to their hospitalization.
Light therapy incorporating ambient Programmed Environmental Illumination (PEI) will be used in patient hospital rooms (during scheduled transplant) to control cancer-related fatigue (CRF).
The FDA has certified that light therapy, like that used in this study, is a low-risk intervention.
When admitted to the hospital for a stem cell transplant, there will be a light fixture in the hospital room which the researchers will be testing to see how it may affect cancer related fatigue, sleep quality, and other negative side effects often seen with the transplant and subsequent treatment.
The light fixture will turn on and off by itself in the morning.
There are two treatment arms used in the study, each of the arms uses different light intensities.
The study treatment received, i.e. which of the two lights, will be chosen by chance, like flipping a coin.
There is an equal chance of being given each study treatment.
Participants will not be told which study treatment they are getting until after the study is completed.
Each light will be turned on from 7 AM to 10AM every day during transplantation.
While in the hospital, assessment of fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue through the course of hospitalization (14-21 days of treatment, to determine immediate impact of sPI), then repeat at one month and three months post-discharge follow-ups (to determine lasting effects).
Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin from urine collection, blood inflammatory markers, all explained below).
This trial will: 1) be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore possible circadian rhythm mediation via melatonin analysis and blood analysis.
This investigation will have major public health relevance as it will determine if an inexpensive and low patient burden intervention (sPI) is able to control fatigue associated with medical illnesses and related problems.
研究概览
研究类型
介入性
注册 (实际的)
73
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10029
- ICAHN School of Medicine at Mount Sinai
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Who will undergo their first autologous HSCT procedure as treatment for multiple myeloma
AND:
- Who are currently 21 years of age or older
- English language proficient
- Able to provide informed consent
Exclusion Criteria:
- Under age 21
- Previous HSCT procedure (autologous or allogeneic)Pregnancy
- Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
- Secondary cancer diagnosis within the last 5 years
- Severe sleep disorders (e.g., Narcolepsy)
- History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
- Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
- Previous use of light therapy to alleviate fatigue or depressive symptoms
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PEI Experimental Light
Ambient light fixture installed in the patient's hospital room
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Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
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有源比较器：Comparison Light
Ambient light fixture installed in the patient's hospital room
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Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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FACIT-Fatigue Scale
大体时间：Baseline, Day 2, 7, 14, 28 and 90
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The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
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Baseline, Day 2, 7, 14, 28 and 90
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Multidimensional Fatigue
大体时间：up to 3 months
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The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue.
It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity.
Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).
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up to 3 months
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The Pittsburgh Sleep Quality Index
大体时间：Baseline, Day 30 and Day 90
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The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
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Baseline, Day 30 and Day 90
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SF-36 Scale
大体时间：Baseline and 30 days post hospital discharge
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Quality of life assessed using the SF-36 scale.
The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability
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Baseline and 30 days post hospital discharge
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Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
大体时间：Baseline, Day 2, Day 7, and Day 14 post transplant
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Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance.
Full score from 0- 20, with higher score indicating more symptomology.
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Baseline, Day 2, Day 7, and Day 14 post transplant
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CES-D (Center for Epidemiologic Studies Depression Scale)
大体时间：Baseline, Day 2, 7, 14, 28, and 90
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CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance.
Full score from 0- 20, with higher score indicating more symptomology.
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Baseline, Day 2, 7, 14, 28, and 90
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The Positive and Negative Affect Schedule (PANAS)
大体时间：Baseline, Day 30, Day 90
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PANAS is a 20-item self-report measure of positive and negative affect.
Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms.
Change in PANAS at Day 30 and Day 90 as compared to baseline.
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Baseline, Day 30, Day 90
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Change in Brief Symptoms Inventory-18 (BSI-18)
大体时间：Baseline and Day 90
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Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument.
Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults.
A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
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Baseline and Day 90
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Fatigue Line Scale
大体时间：baseline, day 2, 7, and 14
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Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue.
Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.
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baseline, day 2, 7, and 14
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Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
大体时间：Baseline, Day 30 after Discharge, Day 90 after Discharge
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Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor.
Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely).
The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.
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Baseline, Day 30 after Discharge, Day 90 after Discharge
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Sleep Latency
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep Efficiency
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Wake Time
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Wake time measured by actigraph.
Wake time is the average number of minutes the participant spent awake each night during the 5 day period.
Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Wake Percent
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep Time
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep time measured by actigraph.
Sleep time - average number of minutes the participant was asleep each night during the 5 day period.
Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep Percent
大体时间：Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Sleep percent measured by actigraph.
Sleep percent is the percent of time spent in bed that the participant is asleep.
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Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
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Melatonin
大体时间：Baseline and Discharge
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Melatonin level
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Baseline and Discharge
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月22日
初级完成 (实际的)
2019年1月23日
研究完成 (实际的)
2019年1月23日
研究注册日期
首次提交
2017年6月21日
首先提交符合 QC 标准的
2017年6月22日
首次发布 (实际的)
2017年6月26日
研究记录更新
最后更新发布 (实际的)
2020年8月11日
上次提交的符合 QC 标准的更新
2020年7月27日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PEI Experimental Light的临床试验
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Medical College of Wisconsin终止