Systematic Light Exposure for Fatigue in Stem Cell Transplant Survivors

 描述(申请人提供)：癌症相关性疲劳(CRF)是最常见的癌症副作用，在药物治疗结束后很长一段时间内会严重干扰日常生活活动。治疗慢性肾功能衰竭的药理药物已经研究过，但没有足够的证据推荐使用。对慢性肾功能衰竭的非药物干预也进行了研究，但实施成本高昂，涉及重大的患者负担。本研究调查了一种新的低成本/低负担的干预措施：系统性明亮白光(BWL)暴露治疗CRF。200名多发性骨髓瘤和弥漫性大B细胞淋巴瘤自体干细胞移植(ASCT)后100至160天的幸存者将从两个医学中心招募，并随机分为两种情况之一：BWL或暗红光(DRL)，这是LIGH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条件将包括暴露于较弱的红光(&lt；50勒克斯)。两个小组将从相同的角度自我管理30分钟的光线 出现盒子4周。将在五个不同的时间点，包括基线和后续行动，通过标准化的主观和客观措施对结果进行评估。这项研究将特别针对NCI临床试验计划会议(JNCI，2013)提出的CRF干预建议。拟议的研究将：1)成为第一个大型多部位随机对照试验，仔细描述比较条件，以调查光对ASCT幸存者CRF的影响；2)专注于不同的、同质的患者群体；3)仅包括经历过临床水平CRF的幸存者；以及4)解决可能的心理和生物机制。这次RCT将有主要的

 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