Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue
PEI
1 other identifier
interventional
73
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 22, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2019
CompletedResults Posted
Study results publicly available
August 11, 2020
CompletedAugust 11, 2020
July 1, 2020
2.5 years
June 21, 2017
March 5, 2020
July 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FACIT-Fatigue Scale
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Baseline, Day 2, 7, 14, 28 and 90
Secondary Outcomes (16)
Multidimensional Fatigue
up to 3 months
The Pittsburgh Sleep Quality Index
Baseline, Day 30 and Day 90
SF-36 Scale
Baseline and 30 days post hospital discharge
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
Baseline, Day 2, Day 7, and Day 14 post transplant
CES-D (Center for Epidemiologic Studies Depression Scale)
Baseline, Day 2, 7, 14, 28, and 90
- +11 more secondary outcomes
Study Arms (2)
PEI Experimental Light
EXPERIMENTALAmbient light fixture installed in the patient's hospital room
Comparison Light
ACTIVE COMPARATORAmbient light fixture installed in the patient's hospital room
Interventions
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
Eligibility Criteria
You may qualify if:
- Who will undergo their first autologous HSCT procedure as treatment for multiple myeloma
- AND:
- Who are currently 21 years of age or older
- English language proficient
- Able to provide informed consent
You may not qualify if:
- Under age 21
- Previous HSCT procedure (autologous or allogeneic)Pregnancy
- Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
- Secondary cancer diagnosis within the last 5 years
- Severe sleep disorders (e.g., Narcolepsy)
- History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
- Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
- Previous use of light therapy to alleviate fatigue or depressive symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Relatively small sample size and did not include post-hospitalization assessments of depressive symptoms. Third, the potential mechanisms underlying the effects of BWL on depressive symptoms were not examined.
Results Point of Contact
- Title
- Heiðdís B. Valdimarsdottir
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
William H. Redd, Ph.D.
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Neither the study participant nor the research coordinator know that study condition of the patient.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 26, 2017
Study Start
July 22, 2016
Primary Completion
January 23, 2019
Study Completion
January 23, 2019
Last Updated
August 11, 2020
Results First Posted
August 11, 2020
Record last verified: 2020-07