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

• 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
• 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

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

项目摘要 与癌症相关的疲劳（CRF）是与癌症和/或治疗有关的持续疲惫。 CRF是 治疗期间最严重，可能会严重干扰日常生活的活动。药理学 已经研究了治疗CRF的代理商，但没有足够的证据建议使用它们。非- 还研究了CRF的药理学干预措施，但实施和涉及 特别是患者负担，特别是在积极治疗的患者中。考虑到CRF的临床影响， 该项目的目的是调查一种新型的低成本/低负担干预措施：系统光 暴露（SLE）治疗CRF。接受辅助剂的228名乳腺癌（BC）患者 化学疗法将从西奈山医学中心，罗斯福医院和纪念馆招募 斯隆kettering癌症中心，并随机分为两个条件之一：明亮的白光（BWL）或昏暗 红光（DRL），这是光研究中的常见比较条件。 BWL干预包括 暴露于全光谱明亮的光线，而DRL条件将涉及暴露于较少的情况 红灯（<50 lux）。这两组将自我辅助30分钟的光线从相同的盒子出现 每天在4个化学疗法的4个周期中。结果将通过标准化的主观评估 和客观措施在八个单独的时间点。该研究将专门解决 NCI临床试验计划会议上的CRF干预措施提出的建议 （JNCI，2013年）。拟议的研究将是第一个大型多站点随机对照试验（RCT）to：1） 确定SLE是否影响接受辅助化疗的卑诗省患者中的CRF； 2）调查 SLE是否可以改善睡眠和抑郁症状，并使昼夜节律正常化和昼夜 皮质醇节奏； 3）探索睡眠，昼夜活动/皮质醇节奏的可能中介作用， 和抑郁症状4）可以广泛且廉价地传播的测试和干预 对患者没有伤害； 5）将NCI确定为重中之重的调查领域。 这个RCT将有专业