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. PUBLIC HEALTH RELEVANCE: The proposed RCT investigates systematic light exposure to treat cancer-related fatigue among 200 Multiple Myeloma and Diffuse Large B-Cell Lymphoma survivors who were treated with autologous stem cell transplant. Bright white light will be compared against dim red light (standard control condition in light studies) in terms of impact on fatigue, sleep problems, and depressive symptoms. The study has considerable public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces cancer-related fatigue.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA193523-04
Application #
9613794
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
O'Mara, Ann M
Project Start
2016-01-01
Project End
2020-12-31
Budget Start
2019-01-01
Budget End
2019-12-31
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
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