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.

项目概要 癌症相关疲劳（CRF）是癌症治疗最常见的副作用， 国家综合癌症网络将其定义为“一种令人痛苦的、持续的、主观的” 与癌症或癌症相关的身体、情绪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、生活质量和烦躁。不幸的是，目前可用的干预措施 CRF 充其量也只是有限的效果。已经针对 CRF 研究了药物制剂，但是 没有足够的证据推荐使用它们。非药物干预已显示 临床上有好处，但它们可能是劳动密集型的、昂贵的并且对患者来说很麻烦。光 待研究的疗法包括系统地暴露于蓝白光，假设可以诱导 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，这些节律的破坏已被证明会影响睡眠数量和质量， 癌症患者的抑郁和疲劳。拟议的研究将探讨可接受性， 系统程序光照明（sPI）暴露预防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，在住院后大约两周内提供 干细胞输注。 sPI 将提供适当定时的环境、低电平、蓝白光 患者在住院期间使用旨在提供高昼夜节律刺激的落地灯 当天的进程。参与者将被随机分配到两种治疗条件之一：一种具有 主动干预，以及非主动比较。在住院期间，sPI 将 包括：早上（上午 6 点至上午 10 点）高强度（400 勒克斯），随后强度降低 上午晚些时候到傍晚（上午 10 点到下午 6 点）期间的强度（低于 50 勒克斯），并且在 晚上（下午 6 点至早上 6 点）。非活动比较条件将由低于 20 勒克斯的蓝白色组成 上午 6 点至下午 6 点期间有灯光，下午 6 点至上午 6 点期间没有灯光。 拟议的研究将解决三个具体目标：1）确定 sPI 是否会产生显着的结果 预防/减少 CRF、抑郁、睡眠问题、昼夜节律的发展 与对比光照条件相比，生活质量受到干扰和下降。 2）探索 sPI 对 CRF 的影响是否是由睡眠变化、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， 体动记录仪、尿液收集和光照监测。