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: 9927596
• 负责人: William H Redd
• 金额: $ 70.06万
• 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/9927596
• 关键词: Activities of Daily Living; Address; Adjuvant; Adjuvant Chemotherapy; Affect; Anthracycline; 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; Reporting; Research; Role; Self Administration; Site; Sleep; Sleep Disorders; Standardization; Symptoms; Testing; Time; Woman; Work; Yoga; actigraphy; active method; cancer therapy; center for epidemiological studies depression scale; chemotherapy; circadian; control trial; cost; depressive symptoms; exhaustion; experience; improved; light effects; malignant breast neoplasm; meetings; novel; patient population; patient tolerability; prevent; public health relevance; recruit; side effect; 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 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 治疗期间最严重，可严重干扰日常生活活动。药理学 已经研究了治疗CRF的药物，但没有足够的证据推荐使用。非 还研究了CRF的药物干预，但实施成本高， 严重的患者负担，特别是在积极治疗的患者中。考虑到CRF的临床影响， 本项目的目标是研究一种新的低成本/低负担的干预措施：系统照明 暴露（sLE）治疗CRF。248例接受辅助治疗的乳腺癌（BC）患者 化疗将从西奈山医疗中心，罗斯福医院和纪念医院招募 Sloan Kettering癌症中心，并随机分为两种条件之一：明亮的白色光（BWL）或昏暗的 红光（DRL），光研究中常见的比较条件。BWL干预措施包括 暴露于全光谱强光，而DRL条件将涉及暴露于较低强度的 红光（< 50勒克斯）。两组人都将从外观相同的盒子中自我管理30分钟的光线 在4个化疗周期中每天一次。将通过标准化的主观评价评估结局。 以及八个不同时间点的客观测量。该研究将具体探讨 NCI临床试验计划会议对CRF干预措施提出的建议 (JNCI该研究将是第一个大型多中心随机对照试验（RCT），以：1） 确定接受辅助化疗的BC患者中sLE是否影响CRF; 2）研究 sLE是否改善睡眠和抑郁症状，并使昼夜活动和昼夜节律正常化 皮质醇节律; 3）探索睡眠，昼夜活动/皮质醇节律， 4）可以广泛和廉价传播的测试和干预 对患者没有伤害;和5）解决NCI确定为最优先的调查领域。 该RCT将具有重大