NCT03198754

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the weeks to months prior to their hospitalization. Light therapy incorporating ambient Programmed Environmental Illumination (PEI) will be used in patient hospital rooms (during scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that light therapy, like that used in this study, is a low-risk intervention. When admitted to the hospital for a stem cell transplant, there will be a light fixture in the hospital room which the researchers will be testing to see how it may affect cancer related fatigue, sleep quality, and other negative side effects often seen with the transplant and subsequent treatment. The light fixture will turn on and off by itself in the morning. There are two treatment arms used in the study, each of the arms uses different light intensities. The study treatment received, i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an equal chance of being given each study treatment. Participants will not be told which study treatment they are getting until after the study is completed. Each light will be turned on from 7 AM to 10AM every day during transplantation. While in the hospital, assessment of fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue through the course of hospitalization (14-21 days of treatment, to determine immediate impact of sPI), then repeat at one month and three months post-discharge follow-ups (to determine lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin from urine collection, blood inflammatory markers, all explained below). This trial will: 1) be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore possible circadian rhythm mediation via melatonin analysis and blood analysis. This investigation will have major public health relevance as it will determine if an inexpensive and low patient burden intervention (sPI) is able to control fatigue associated with medical illnesses and related problems.

Conditions

• Cancer-related Problem/Condition
• Depression
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DEVICE	PEI Experimental Light	Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
DEVICE	Comparison Light	Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

Timeline

• Start date: 2016-07-22
• Primary completion: 2019-01-23
• Completion: 2019-01-23
• First posted: 2017-06-26
• Last updated: 2020-08-11
• Results posted: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study