Clinical trial NCT03198754: Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue
Official title: Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Depression
Circadian Rhythm Disorders
Keywords: Autologous Stem Cell Transplant
Multiple Myeloma
oncology
circadian rhythms
light therapy
Hematopoietic stem cell transplantation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: FACIT-Fatigue Scale
timeFrame: Baseline, Day 2, 7, 14, 28 and 90
Secondary outcomes:
measure: Multidimensional Fatigue
timeFrame: up to 3 months
measure: The Pittsburgh Sleep Quality Index
timeFrame: Baseline, Day 30 and Day 90
measure: SF-36 Scale
timeFrame: Baseline and 30 days post hospital discharge
measure: Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
timeFrame: Baseline, Day 2, Day 7, and Day 14 post transplant
measure: CES-D (Center for Epidemiologic Studies Depression Scale)
timeFrame: Baseline, Day 2, 7, 14, 28, and 90
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, Day 30, Day 90
measure: Change in Brief Symptoms Inventory-18 (BSI-18)
timeFrame: Baseline and Day 90
measure: Fatigue Line Scale
timeFrame: baseline, day 2, 7, and 14
measure: Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
timeFrame: Baseline, Day 30 after Discharge, Day 90 after Discharge
measure: Sleep Latency
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Sleep Efficiency
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Wake Time
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Wake Percent
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Sleep Time
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Sleep Percent
timeFrame: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
measure: Melatonin
timeFrame: Baseline and Discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: William H. Redd, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: