Systematic Programmed Illumination (sPI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoeitic Stem Cell Transplantation for Multiple Myeloma

医院病房的系统程序照明 (sPI) 可预防/减少多发性骨髓瘤造血干细胞移植期间与癌症相关的疲劳

• 批准号: 9322328
• 负责人: William H Redd
• 金额: $ 18.11万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9322328
• 关键词: Address; Adverse effects; Affect; Agitation; Alzheimer' s Disease; Autologous Stem Cell Transplantation; Behavior; Brain; Breast Cancer Patient; Cancer Intervention; Cancer Patient; Circadian Rhythms; Clinical; Cognitive; Collection; Confounding Factors (Epidemiology); Development; Distress; Emotional; Exposure to; Fatigue; Floor; High Prevalence; Hospitalization; Hospitals; Hour; Immune system; Infusion procedures; Inpatients; Institutes; Intervention; Investigation; Laboratories; Length of Stay; Light; Lighting; Logic; Malignant Neoplasms; Measures; Mediating; Medical; Medical center; Melatonin; Mental Depression; Monitor; Multiple Myeloma; National Comprehensive Cancer Network; Obesity; Outcome; Participant; Patient Schedules; Patients; Pharmacology; Phototherapy; Physiological; Play; Prevention; Prospective Studies; Quality of life; Randomized; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Role; Sampling; Series; Sleep; Sleep Disorders; Standardization; Stem cell transplant; Stem cells; Study models; Transplantation; Treatment-Related Cancer; Urine; Work; actigraphy; biopsychosocial; cancer therapy; center for epidemiological studies depression scale; chemotherapy; depressive symptoms; design; diabetes risk; exhaustion; follow-up; light effects; patient population; prevent; public health relevance

PROJECT SUMMARY Cancer-related fatigue (CRF) is the most commonly reported side effect of cancer treatment and is defined by the National Comprehensive Cancer Network as “a distressing, persistent, subjective sense of physical, emotional, and cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity.” Such fatigue is often associated with sleep problems, depression, quality of life, and agitation. Unfortunately, currently available interventions for CRF are, at best, only modestly effective. Pharmacological agents have been studied for CRF, but there is insufficient evidence to recommend their use. Non-pharmacological interventions have shown clinical benefit, but they can be labor-intensive, expensive, and cumbersome for patients. The light therapy to be studied incorporates systematic exposure to bluish-white light is hypothesized to entrain circadian rhythms, which play a crucial role in the cellular and physiological functions of the brain and body. Indeed, disruption of these rhythms has been shown to affect sleep quantity and quality, depression, and fatigue among cancer patients. The proposed research will explore the acceptability, feasibility and potential efficacy of systematic programmed light illumination (sPI) exposure to prevent CRF in patients undergoing autologous stem cell transplantation in the treatment of Multiple Myeloma, as provided during their inpatient hospital stay for approximately two weeks following infusion of stem cells. sPI will deliver appropriately timed ambient, low-level, bluish-white light to patients during their hospital stay with floor lamps designed to deliver high circadian stimulation over the course of the day. Participants will be randomized to one of two treatment conditions: one with an active intervention, and one with a non-active comparison. During inpatient hospitalization, sPI will consist of: high intensity (400 lux) during morning hours (6AM to 10AM), followed by a decrease in intensity (lower than 50 lux) during late morning to early evening hours (10AM to 6PM), and no sPI at night (6PM to 6AM). The non-active comparison condition will consist of less than 20 lux blue-white light during 6AM-6PM period and no light from 6PM-6AM. The proposed research will address three specific aims: 1) Determine if sPI results in significant prevention/reduction of the development of CRF, depression, sleep problems, circadian rhythm disruption and diminished quality of life compared to the comparison light condition. 2) Explore whether the effects of sPI on CRF are mediated by changes in sleep, depressive symptoms, circadian activity rhythms, and/or melatonin 3) Determine the feasibility and acceptability of sPI, actigraphy, urine collection and monitoring of light exposure.

项目摘要 与癌症有关的疲劳（CRF）是癌症治疗中最常见的副作用，是 由国家综合癌症网络定义为“令人沮丧，持久，主观的 与癌症或癌症有关的身体，情感和认知疲倦或疲惫感 与最近活动不成比例的治疗。”这种疲劳通常与睡眠有关 问题，抑郁，生活质量和躁动。不幸的是，目前可用的干预措施 CRF充其量只有适度的有效。药理学剂已经研究了CRF，但 没有足够的证据建议使用它们。非药理学干预已显示 临床益处，但它们可能是实验室密集型，昂贵且对患者来说很麻烦。光 假设将用于研究的治疗纳入系统暴露于蓝白色的光线 昼夜节律，在大脑的细胞和生理功能中起着至关重要的作用 身体。确实，这些节奏的破坏已被证明会影响睡眠数量和质量， 癌症患者的抑郁症和疲劳。拟议的研究将探索可接受性 系统编程光照射（SPI）暴露的可行性和潜在有效性以防止 接受自体干细胞移植的患者的CRF治疗多种 骨髓瘤，如他们在住院住院期间提供的大约两个星期 输注干细胞。 SPI将提供适当定时的环境，低级，蓝白色的光 病人在住院期间留下旨在提供高昼夜刺激的落地灯 一天的过程。参与者将被随机分为两个治疗条件之一：一个 主动干预，一个进行非活动比较。在住院住院期间，SPI将 包括：早晨（上午6点至上午10点）高强度（400 lux），然后减少 强度（低于50 Lux）在清晨至傍晚（上午10点至下午6点），而没有SPI 晚上（下午6点至凌晨6点）。非活动的比较条件将包括少于20个Lux蓝白色 在上午6点至下午6点的灯光，从下午6点至凌晨6点发光。 拟议的研究将针对三个具体目的：1）确定SPI是否会导致重大 预防/减少CRF的发展，抑郁，睡眠问题，昼夜节律 与比较光条件相比，破坏和生活质量降低。 2）探索 SPI对CRF的影响是否是由睡眠变化，抑郁症状的变化介导的， 昼夜节律节奏和/或褪黑激素3）确定SPI的可行性和可接受性， 摄影，尿液收集和光暴露的监测。