Systematic Light Exposure for Fatigue in Stem Cell Transplant Survivors

 描述（由申请人提供）：癌症相关疲劳（CRF）是最常见的癌症副作用，在完成药物治疗后很长时间内会严重干扰日常生活活动。已经研究了治疗CRF的药物，但没有足够的证据推荐使用。还研究了CRF的非药物干预，但实施成本高，患者负担重。本研究探讨了一种新的低成本/低负担的干预措施：系统的明亮白色光（BWL）暴露治疗CRF。将从两个医学中心招募200名自体干细胞移植（ASCT）后100至160天的多发性骨髓瘤和弥漫性大B细胞淋巴瘤的幸存者，并随机分配至两种条件之一：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）。两组人都将在相同的时间内自行管理30分钟的光照， 出现盒子4周。将通过标准化的主观和客观指标在五个不同的时间点（包括基线和随访）评估结局。本研究将专门讨论NCI临床试验计划会议提出的CRF干预措施建议（JNCI，2013）。拟议的研究将：1）是第一个大型多中心RCT，具有仔细描述的比较条件，以研究ASCT幸存者中光对CRF的影响; 2）关注独特的同质患者人群; 3）仅包括经历临床水平CRF的幸存者;和4）解决可能的心理和生物机制。该RCT将具有重大

 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