Systematic Light Exposure to treat Cancer-Related Fatigue in Breast Cancer Patients

系统性光照治疗乳腺癌患者与癌症相关的疲劳

基本信息

批准号：
9310766
负责人：
William H Redd
金额：
$ 73.64万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-05-17 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9310766
关键词：
Activities of Daily Living Address Adjuvant Adjuvant Chemotherapy Adverse effects Affect Anthracyclines Area Breast Cancer Patient Cancer Intervention Cancer Patient Cancer Survivor Circadian Rhythms Clinical Clinical Trials Cognition Cognitive Therapy Effectiveness Exercise Exposure to Fatigue Feasibility Studies Goals Hospitals Hydrocortisone Hypnosis Intervention Investigation Life Light Malignant Neoplasms Measures Mediating Medical center Memorial Sloan-Kettering Cancer Center Mental Depression Moods Neoadjuvant Therapy New York City Outcome Participant Patients Pharmacological Treatment Pharmacology Pittsburgh Sleep Quality Index Prevalence Randomized Randomized Clinical Trials Randomized Controlled Trials Recommendation Recruitment Activity Reporting Research Role Self-Administered Site Sleep Sleep Disorders Standardization Symptoms Testing Time Woman Work Yoga actigraphy active method cancer therapy center for epidemiological studies depression scale chemotherapy cost depressive symptoms exhaustion experience improved light effects malignant breast neoplasm meetings novel patient population prevent public health relevance social

项目摘要

PROJECT SUMMARY Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most severe during treatment and can severely interfere with activities of daily living. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non- pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel low-cost/low-burden intervention: systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant chemotherapy will be recruited from Mount Sinai Medical Center, Roosevelt Hospital, and Memorial Sloan Kettering Cancer Center and randomized to one of two conditions: bright white light (BWL) or dim red light (DRL), a common comparison condition in light studies. The BWL intervention consists of exposure to full spectrum bright light whereas the DRL condition will involve exposure to less intense red light (< 50 lux). Both groups will self-administer 30 minutes of light from identically appearing boxes daily throughout 4 cycles of chemotherapy. Outcomes will be assessed through standardized subjective and objective measures at eight separate time points. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI,2013).The proposed study will be the first large multisite randomized control trial (RCT) to: 1) determine if sLE affects CRF among BC patients undergoing adjuvant chemotherapy; 2) investigate whether sLE improves sleep and depressive symptoms and normalizes circadian activity and diurnal cortisol rhythms; 3) explore the possible mediational roles of sleep, circadian activity/cortisol rhythms, and depressive symptoms 4) test and intervention that can be widely and inexpensively disseminated with no harm to patients; and 5) address areas of investigation identified by the NCI as a top priority. This RCT will have major

项目概要癌症相关疲劳（CRF）是与癌症和/或其治疗相关的持续性疲惫。 CRF 是在治疗期间最为严重，并可能严重干扰日常生活活动。药理作用已经研究了治疗 CRF 的药物，但没有足够的证据推荐使用它们。非- 针对 CRF 的药物干预也已得到研究，但实施成本高昂且涉及显着的患者负担，尤其是那些正在积极治疗的患者。鉴于 CRF 的临床影响，该项目的目标是研究一种新颖的低成本/低负担干预措施：系统光暴露（sLE）以治疗 CRF。 248 名乳腺癌 (BC) 患者接受辅助治疗化疗将从西奈山医疗中心、罗斯福医院和纪念医院招募斯隆凯特琳癌症中心并随机分配到以下两种情况之一：亮白光 (BWL) 或昏暗红光（DRL），光研究中常见的比较条件。 BWL 干预包括暴露在全光谱强光下，而 DRL 条件将涉及暴露在不太强烈的光下红光（< 50 lux）。两组都将在外观相同的盒子中自行进行 30 分钟的光照在 4 个化疗周期中每天一次。结果将通过标准化主观评估以及八个不同时间点的客观测量。该研究将具体解决 NCI 临床试验计划会议对 CRF 干预措施提出的建议（JNCI，2013）。拟议的研究将是第一个大型多中心随机对照试验（RCT）：1）确定 sLE 是否影响接受辅助化疗的 BC 患者的 CRF； 2）调查 sLE 是否可以改善睡眠和抑郁症状并使昼夜节律活动和昼夜正常化皮质醇节律； 3）探索睡眠、昼夜节律活动/皮质醇节律的可能中介作用，和抑郁症状 4) 可以广泛且廉价地传播的测试和干预对患者无伤害； 5) 解决 NCI 确定的首要调查领域。这个随机对照试验将有主要