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

Public Health Relevance

as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF. Specific Aims: Aim 1: Assess whether BWL compared with DRL yields significant reductions in CRF. Aim 2: Determine whether the BWL compared with DRL affects sleep, activity circadian rhythms, and depressive symptoms. Aim 3: Examine whether the effects of BWL are mediated by changes in sleep, depressive symptoms, and/or activity circadian rhythms. Exploratory Aim 4: Investigate whether the BWL compared with DRL normalizes cortisol circadian rhythms and whether the effects of BWL on CRF are mediated by changes in cortisol circadian rhythms.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA193523-01A1
Application #
9028574
Study Section
Special Emphasis Panel (ZCA1-RPRB-M (O1))
Program Officer
O'Mara, Ann M
Project Start
2016-01-01
Project End
2020-12-31
Budget Start
2016-01-01
Budget End
2016-12-31
Support Year
1
Fiscal Year
2016
Total Cost
$725,495
Indirect Cost
$206,222
Name
Icahn School of Medicine at Mount Sinai
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029