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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