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

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ClinicalTrials.gov Identifier: NCT03198754
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
William H. Redd, 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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Depression Circadian Rhythm Disorders Device: PEI Experimental Light Device: Comparison Light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Neither the study participant nor the research coordinator know that study condition of the patient.
Primary Purpose: Supportive Care
Official Title: Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
Actual Study Start Date : July 22, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEI Experimental Light
Ambient light fixture installed in the patient's hospital room
Device: PEI Experimental Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

Active Comparator: Comparison Light
Ambient light fixture installed in the patient's hospital room
Device: Comparison Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.




Primary Outcome Measures :
  1. FACIT-Fatigue Scale [ Time Frame: up to 3 months ]
    The FACIT-Fatigue scale will be used both for selection of patients into the study and as an outcome measure of fatigue. Smith et al. (1999) report that this 13 item scale has excellent test-retest reliability (r = 0.90) and internal consistency reliability (alpha = 0.93-0.95). In addition, criterion related validity studies using objective measures of physical function as the outcome show that patient reported fatigue based on the FACIT-Fatigue can predict these objective measures. This measure is the main tool for measuring fatigue in the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. Cella (personal communication) has indicated that a FACIT-Fatigue score equal to or less than 33 constitutes clinically significant fatigue.


Secondary Outcome Measures :
  1. Multidimensional Fatigue [ Time Frame: 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).

  2. The Pittsburgh Sleep Quality Index [ Time Frame: up to 3 months ]
    The Pittsburgh Sleep Quality Index consists of 19 self-rated items. Scale reliability is excellent using both an internal consistency criterion (Cronbach's alpha = 0.83) and test-retest reliability (r = 0.85). The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).

  3. SF-36 scale [ Time Frame: Baseline,1 month post hospital discharge, 3 months post hospital discharge ]
    Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. Both test-retest and internal consistency reliability exceeded 0.70 in studies of this scale's psychometric properties. The scale also has demonstrated content, criterion, and predictive validity.

  4. CES-D (Center for Epidemiologic Studies Depression Scale) [ Time Frame: up to 3 months ]
    20 item questionnaire that comprise six scales reflecting major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. The CES-D has been shown to be a reliable measure for assessing the number, types, and duration of depressive symptoms across racial, gender, and age categories (Cronbach's alpha ≥0.80). Concurrent validity by clinical and self-report criteria, as well as substantial evidence of construct validity has been demonstrated.

  5. PANAS [ Time Frame: up to 3 months ]
    The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure of positive and negative affect developed by Watson, Clark, and Tellegen (1988). NA and PA reflect "dispositional dimensions, with high-NA epitomized by subjective distress and unpleasurable engagement, and low NA by the absence of these feelings." Conversely, PA represents the extent to which an individual experiences pleasurable engagement with the environment. Consequently, emotions such as enthusiasm and alertness are indicative of high PA, whilst lethargy and sadness characterize low PA. Both the PA and NA have decent Test-retest reliability (r=0.68 and r=0.71 respectively) and decent Internal Consistency (Cronbach's alpha = 0.87).

  6. Brief Symptoms Inventory-18 (BSI-18) [ Time Frame: up to 3 months ]
    BSI-18 is one an integrated series of instruments designed to measure psychological distress. A more concise version of the 53 item BSI, the BSI-18 boasts 18 items and, according to its authors, this inventory presents satisfactory reliability indexes, both for the dimensions (ranging from .74 to .84) and the general distress index (.89). It has decent Test-retest Reliability (r=0.76) and good Internal Consistency (Cronbach's alpha = 0.89).

  7. Fatigue Line Scale [ Time Frame: up to 7 days ]
    Simple numeric graphic rating scale, marked on a line numbering 0-100. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198754


Contacts
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Contact: Kathryn Sommer, BS 212-659-5645 Kathryn.sommer@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Kathryn Sommer, BS    212-659-5645    kathryn.sommer@mssm.edu   
Principal Investigator: William H. Redd, Ph.D.         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: William H. Redd, Ph.D. Icahn School of Medicine at Mount Sinai

Additional Information:
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Responsible Party: William H. Redd, Associated Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03198754     History of Changes
Other Study ID Numbers: GCO 15-2009
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by William H. Redd, Icahn School of Medicine at Mount Sinai:
Autologous Stem Cell Transplant
Multiple Myeloma
oncology
circadian rhythms
light therapy
Hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Chronobiology Disorders
Fatigue
Signs and Symptoms
Nervous System Diseases