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

基本信息

批准号：
9028574
负责人：
William H Redd
金额：
$ 72.55万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
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/9028574
关键词：
Activities of Daily Living Address Adverse effects Affect Autologous Autologous Stem Cell Transplantation Biological Boxing 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 Pittsburgh Sleep Quality Index Process Randomized Randomized Controlled Trials Recommendation Recruitment Activity Reporting Research Sample Size Sampling Schedule Self-Administered Site Sleep Stem cell transplant Survivors Time Visit Yoga actigraphy clinically significant cost depressive symptoms efficacy testing exhaustion experience follow-up large cell Diffuse non-Hodgkin&apos s lymphoma light effects meetings meter novel patient population psychologic public health relevance randomized trial treatment duration

项目摘要

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，在完成治疗后很长时间内会严重干扰日常生活活动，但没有足够的证据来推荐。也对 CRF 的非药物干预措施进行了研究，但实施成本较高，且患者负担较大。本研究研究了一种新型低成本/低负担干预措施：系统性亮白光 (BWL) 照射治疗。 CRF。将从两个医疗中心招募 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 细胞淋巴瘤幸存者，并随机分配到以下两种条件之一：BWL 或暗红光（ DRL），BWL 干预包括暴露于全光谱强光，而 DRL 条件则涉及暴露于较弱的红光（< 50 lux）。将自行管理 30 分钟的相同光照 4 周的结果将通过标准化的主观和客观测量在五个不同的时间点进行评估，包括基线和随访。该研究将专门针对 NCI 临床试验计划会议 (JNCI， 2013).拟议的研究将：1) 成为第一个大型多部位随机对照试验，具有仔细描述的比较条件，以研究光对 ASCT 幸存者 CRF 的影响；2) 关注不同的、同质的患者群体； 3) 仅包括经历过 CRF 临床水平的幸存者；4) 该随机对照试验将探讨可能的心理和生物学机制。