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 癌症相关性疲劳（CRF）是癌症治疗最常见的副作用， 被国家综合癌症网络定义为“一种令人痛苦的，持续的，主观的， 与癌症或癌症相关的身体、情感和认知疲劳或疲惫感 与最近的活动不成比例的治疗。”这种疲劳通常与睡眠有关 问题、抑郁、生活质量和焦虑。不幸的是，目前可用于 CRF充其量只是适度有效。已经研究了用于CRF的药物制剂，但是 没有足够的证据建议使用这些药物。非药物干预显示， 临床效益，但它们可能是劳动密集型的，昂贵的，和麻烦的病人。光 将要研究的治疗包括系统暴露于蓝白光， 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， 身体事实上，这些节律的中断已经被证明会影响睡眠的数量和质量， 癌症患者的抑郁和疲劳。拟议的研究将探讨可接受性， 系统程序光照（sPI）暴露的可行性和潜在功效， 接受自体干细胞移植治疗多发性骨髓瘤患者的CRF 骨髓瘤，在患者住院期间提供，约两周， 干细胞移植sPI将提供适当的定时环境，低水平，蓝白色光， 患者在住院期间使用落地灯， 一天的进程参与者将被随机分配到两种治疗条件之一：一种是 一种是积极干预，另一种是不积极的比较。在住院期间，sPI将 包括：早晨（上午6点至上午10点）的高强度（400勒克斯），随后是 强度（低于50勒克斯）在上午晚些时候到傍晚（上午10点到下午6点）， 晚上6点到早上6点。非主动比较条件将包括小于20勒克斯的蓝白色 在6AM-6PM期间有光，并且从6PM-6AM没有光。 拟议的研究将解决三个具体目标：1）确定sPI是否会导致显著的 预防/减少CRF、抑郁、睡眠问题、昼夜节律的发展 与比较光条件相比，破坏和降低的生活质量。2)探索 sPI对CRF的影响是否通过睡眠，抑郁症状， 昼夜活动节律和/或褪黑激素3）确定sPI的可行性和可接受性， 活动记录、尿液收集和光暴露监测。