Systematic Light Exposure for Fatigue in Stem Cell Transplant Survivors

系统性光照可缓解干细胞移植幸存者的疲劳

• 批准号: 9191356
• 负责人: William H Redd
• 金额: $ 69.08万
• 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: 2016-01-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9191356
• 关键词: Activities of Daily Living; Address; Adverse effects; Affect; Autologous Stem Cell Transplantation; Biological; Cancer Intervention; Cancer Survivor; Circadian Rhythms; Clinical; Clinical Trials; Cognitive Therapy; Data; Exercise; Exposure to; Fatigue; Hydrocortisone; Hypnosis; Intervention; Investigation; Light; Malignant Neoplasms; Measures; Mediating; Medical; Medical center; Multiple Myeloma; New York City; Outcome; Participant; Patients; Pharmacology; Pittsburgh Sleep Quality Index; Process; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Research; Sample Size; Sampling; Schedule; Self-Administered; Site; Sleep; Sleep Disorders; Standardization; Stem cell transplant; Survivors; Time; Visit; Yoga; actigraphy; clinically significant; cost; depressive symptoms; efficacy testing; exhaustion; experience; follow-up; large cell Diffuse non-Hodgkin' s lymphoma; light effects; meetings; meter; novel; patient population; psychologic; public health relevance; randomized trial; treatment duration

 DESCRIPTION (provided by applicant): Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completionof medical treatment. 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. This study investigates a novel low-cost/low-burden intervention: systematic bright white light (BWL) exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 100 and 160 days post-autologous stem cell transplant (ASCT) will be recruited from two medical centers and randomized to one of two conditions: 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 for 4 weeks. Outcomes will be assessed through standardized subjective and objective measures at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite RCT with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This RCT will have major

 描述（由适用提供）：与癌症相关的疲劳（CRF）是最常见的癌症副作用，可以严重干扰医疗完成后很长时间的日常生活活动。已经研究了治疗CRF的药理学剂，但没有足够的证据建议其使用。还研究了CRF的非药理学干预措施，但实施和涉及大量患者伯恩的昂贵。这项研究调查了一种新型的低成本/低负压干预措施：系统的明亮白光（BWL）以治疗CRF。在自动细胞移植后100至160天之间，多发性骨髓瘤和弥漫性大的B细胞淋巴瘤的两百个存活率将从两个医疗中心募集，并随机分配到两个条件之一：BWL或昏暗的红光（DRL），这是一种在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条件将涉及暴露于不太强烈的红光（<50 lux）。这两组将自我辅助30分钟的光线相同 出现盒子4周。结果将通过标准化的主观和客观测量在五个单独的时间点（包括基线和随访）进行评估。该研究将特别解决NCI临床试验计划会议（JNCI，2013年）对CRF的干预措施的建议。拟议的研究将：1）成为第一个大型多站点RCT，具有仔细描述的比较条件，以研究ASCT幸存中CRF的影响； 2）专注于独特的同质患者人群； 3）仅包括经历CRF临床水平的生存； 4）解决可能的心理和生物学机制。这个RCT将有专业