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

Not Applicable

Completed

• Conditions: Depression; Cancer-related Problem/Condition; Circadian Rhythm Disorders
• Interventions: Device: Comparison Light; Device: PEI Experimental Light

• Registration Number: NCT03198754
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07-22
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Results First Submitted: 2020-03-05
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Results First Posted: 2020-08-11
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Light	Comparison Light	Ambient light fixture installed in the patient's hospital room
PEI Experimental Light	PEI Experimental Light	Ambient light fixture installed in the patient's hospital room

Primary Outcome Measures

Name	Time	Method
FACIT-Fatigue Scale	Baseline, Day 2, 7, 14, 28 and 90	The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.

Secondary Outcome Measures

Name	Time	Method
CES-D (Center for Epidemiologic Studies Depression Scale)	Baseline, Day 2, 7, 14, 28, and 90	CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
Multidimensional Fatigue	up to 3 months	The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).
The Pittsburgh Sleep Quality Index	Baseline, Day 30 and Day 90	The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
SF-36 Scale	Baseline and 30 days post hospital discharge	Quality of life assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
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	Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
The Positive and Negative Affect Schedule (PANAS)	Baseline, Day 30, Day 90	PANAS is a 20-item self-report measure of positive and negative affect. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms. Change in PANAS at Day 30 and Day 90 as compared to baseline.
Change in Brief Symptoms Inventory-18 (BSI-18)	Baseline and Day 90	Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
Fatigue Line Scale	baseline, day 2, 7, and 14	Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)	Baseline, Day 30 after Discharge, Day 90 after Discharge	Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely). The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.
Sleep Latency	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Sleep Efficiency	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Wake Time	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Wake time measured by actigraph. Wake time is the average number of minutes the participant spent awake each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Wake Percent	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
Sleep Time	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Sleep Percent	Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge	Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.
Melatonin	Baseline and Discharge	Melatonin level

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States