Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma
Phase: NA
Conditions: Cancer-related Problem/Condition, Depression, Circadian Rhythm Disorders
Sponsor: Icahn School of Medicine at Mount Sinai

Systematic Programmed Illumination of Hospital Rooms to
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell
Transplantation for Multiple Myeloma
PI: William H Redd, Ph.D
NCT03198754  
Document Date: August 15, 2019

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
1 
Revised 9/2/14 
Brief Summary of Research (250-400 words): 
Patients who receive autologous hematopoietic stem cell transplantation (HSCT) in the treatment of 
Multiple Myeloma (MM) are typically hospitalized for 14-21 days during their transplant and medically 
stabilize afterwards as part of standard care. It is before, during, and after this hospitalization for 
transplant that our study will take place. 
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 systematic programmed light 
illumination (sPI) 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. After initial assessment of CRF, depression, and sleep quality/quantity (baseline 
assessments), participants will be randomized to one of two treatment conditions: one with an active 
intervention, and one with a non-active comparison. During inpatient hospitalization, the active 
intervention will consist of the following regimen: high intensity bright-white light (1300 lux at the eyes) 
during morning hours (7AM to 10AM). The non-active comparison condition will receive half the intensity 
dim-white light of  the active group (i.e., 90 lux at the eyes) during 7AM-10AM. These differences in lux 
intensity are not easily discernable. Following baseline, 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 threemonths 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. 
1) Objectives
Specific Aims: 

Aim 1: Determine if sPI results in significant prevention/reduction of the development of CRF,
depression, sleep problems, circadian rhythm disruption and diminished quality of life
compared to the comparison light condition. Hypothesis 1a: HSCT patients exposed to sPI will
report less CRF (measured by FACIT-Fatigue Scale), less depressive symptoms (measured by the
CES-D/BDI-II), better sleep (measured subjectively by the Pittsburgh Sleep Quality Index, FACIT
Fatigue Scale and objectively by actigraphy), and more synchronized activity circadian rhythms
(measured by actigraphy) during the course of HSCT hospitalization compared to those patients in
the low light comparison condition. Hypothesis 1b: HSCT patients receiving sPI will report positive
effects on CRF, depression, sleep, and circadian rhythm disruption at  one month and three-

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
2 
Revised 9/2/14 
months after discharge and completion of the sPI intervention than those in the comparison 
condition. 

Aim 2: Explore whether the effects of sPI are mediated by changes in sleep, depressive
symptoms, activity circadian rhythms, melatonin and/or inflammatory markers. Hypothesis 2a:
The effects of sPI on CRF are mediated by changes in sleep quality. Hypothesis 2b: The effects of
sPI on CRF are mediated by changes in depressive symptoms. Hypothesis 2c: The effects of sPI on
CRF are mediated by changes in activity circadian rhythms (measured via actigraphy and
melatonin rhythmicity). Hypothesis 2d: the effects of sPI on CRF are mediated by changes in
inflammatory markers.Aim 3: Determine the feasibility and acceptability of sPI, actigraphy, urine
collection and monitoring of light exposure. Hypothesis 3a: Initiating the sPI environment in
patient hospital rooms during inpatient procedures (HSCT and initial chemotherapy regimen to
treat MM and related oncological diseases) will be tolerable among MM-HSCT patients and
medical professionals. Hypothesis 3b: sPI will be feasible as an inpatient treatment method to
prevent common circadian rhythm-based side effects observed with HSCT and subsequent
chemotherapy. Hypothesis 3c: sPI implementation inpatient hospital rooms will maximize
potential patient benefit while minimizing deviation from normal lighting fixture end-user
experience for both HSCT patients and medical professionals. Hypothesis 3d: Actigraphy collection
among HSCT patients will be acceptable as an assessment method before, during, and after HSCT.
Hypothesis 3e: Urine collection among HSCT patients will be tolerable as an assessment method
before and during hospital visit for HSCT. Hypothesis 3f: Monitoring of light exposure via
Daysimeter data among HSCT patients will be acceptable as an assessment method before and
during HSCT.
2) Background
Debilitating fatigue – a persistent sense of exhaustion frequently associated with a number of serious 
medical conditions, including cancer – can interfere with mood, activities of daily living, treatment 
compliance. Such fatigue is often associated with sleep problems, depression, quality of life, and 
agitation. Unfortunately, currently available interventions for CRF are, at best, only modestly effective. 
Pharmacological agents have been studied for CRF, but there is insufficient evidence to recommend their 
use. Non-pharmacological interventions have shown clinical benefit, but they can be labor-intensive, 
expensive, and cumbersome for patients. A promising alternative is light therapy.  
Although CRF is well documented, it is difficult to characterize because it has a poorly delineated etiology. 
Circadian rhythm disruption (CRD) has been hypothesized to play an important role in the etiology of CRF 
by affecting multiple domains of psychosocial and physiological functioning. Circadian rhythms are 
generated and regulated by an internal biological clock located in the suprachiasmatic nucleus of the 
hypothalamus; they are biological cycles (e.g., changes in hormone secretion, body temperature, and 
sleep-wake activity cycles) that are slightly longer than 24 hours and are entrained to the 24-hour day by 
environmental time cues.  
Bright light is one of the strongest synchronizers of circadian rhythms, which are maintained through 
entrainment by light exposure to the retina. Light therapy incorporating systematic exposure to bluish-

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
3 
Revised 9/2/14 
white light is hypothesized to entrain circadian rhythms, which play a crucial role in the cellular and 
physiological functions of the brain and body. Indeed, disruption of these rhythms has been shown to 
affect sleep quantity and quality, depression, and fatigue among cancer patients. The proposed research 
will investigate the delivery of sPI via a novel delivery system to treat CRF, experienced by up to 80% of all 
cancer patients. Although CRF has been found to be related to CRD and it is known that bright light 
improves rhythms, the effect of sPI on CRF has not been investigated. Further, CRF has been found to be 
related to sleep disturbances, as well as to depression, yet the effect of sPI on these effects has not been 
explored. 
Inflammatory response have been proposed to underlie CRF.  There is an association between CRF among 
cancer patients and activation of pro-inflammatory signaling. For example, breast cancer survivors with 
persistent fatigue have elevated levels of markers associated with pro-inflammatory cytokine activity 
including Interleukin-1 receptor antagonist (IL-1ra), Interleukin-6 (IL-6), soluble tumor necrosis factor receptor 
type II (sTNF-RII), soluble intercellular adhesion molecule-1 (sICAM-1), and C-reactive protein (CRP). It has also 
been shown that chemotherapy leads to significant elevations in inflammation which is associated with 
increases in fatigue.  
In the proposed preliminary feasibility research, sPI will deliver appropriately timed ambient, low-level, 
bluish-white light to patients during their hospital stay with floor lamps designed to deliver high circadian 
stimulation in the morning. We have selected cancer patients who are hospitalized for HSCT to treat MM 
because this population: (1) is relatively homogenous with a high prevalence of CRF, (2) can be studied 
prospectively across the course of HSCT, (3) permits careful monitoring of circadian rhythm entrainment 
through analysis of melatonin from urine obtained before, during and after HSCT, (4) regularly has blood 
drawn for clinical purposes and (5) allows assessment and control of confounding variables.  
Preliminary research: 
The proposed exploratory study builds on Redd’s, Figueiro’s, and Ancoli-Israel’s complementary areas of 
research. Redd, Ancoli-Israel and colleagues’ ongoing investigation of BWL to treat CRF in cancer 
(including HSCT) survivors has formed the conceptual template for the proposed study and points to the 
potential importance of sPI in the prevention and treatment of CRF. In previous studies, they were able to 
retain 71% of participants, a retention rate that we also expect for the proposed protocol.  
Both Redd’s and Ancoli-Israel’s work supports the proposed study in 6 ways: (1) It provides the conceptual 
rationale for light as an intervention for negative sequelae of cancer treatment; (2) It established the 
acceptability of light treatment by cancer patients; (3) It determined the overall feasibility of lighting 
interventions with a cancer population, indicating that patients were: a) able to implement the light 
intervention with minimal involvement by research staff, b) adherent to home-based treatment regimens, 
and c) able to successfully complete all study assessments; (4) It confirms a low-lux light treatment as an 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
4 
Revised 9/2/14 
appropriate comparison condition; (5) It provides clear procedural guidelines; (6) It demonstrates the 
importance of examining sPI for the treatment of negative cancer sequelae as patients exposed to daily 
light entrainment showed clinical benefit.  
Figueiro has shown that using an ambient light treatment can improve sleep and behavior in patients with 
Alzheimer’s disease and related dementia. Using knowledge of human circadian phototransduction, which 
is how the retina converts light signals into neural signals to the brain, Figueiro was able to provide most 
of the ambient light’s radiant power in a range that has the greatest effect on circadian rhythms. This 
allows us to reduce overall sPI light levels and make the emitted light more comfortable for patients, 
possibly increasing treatment compliance. 
 
Recent work by Ancoli-Israel, Redd, and Liu revealed that breast cancer and HSCT patients were light-
deprived. Compared to healthy adults in an illumination study who received 58 minutes of bright light per 
day, breast cancer patients during chemotherapy received only 35 minutes of bright light per day, and 
HSCT patients in our preliminary light exposure study for cancer-related fatigue only received 30 minutes 
of bright light per day. Their findings provide additional evidence that sPI may hold promise for patients 
who are light deprived. 
 
3)  Setting of the Human Research 
 
Research procedures will be performed at the Icahn School of Medicine at Mount Sinai (MSH) and the 
Rensselaer’s Lighting Research Center (RLC).  
 
The RPI LRC Biomarker Lab staff will be responsible for processing urine specimens, informing and 
assisting with all protocols performed at MSH, processing and analyzing data, and writing reports. The IRB 
at Rensselaer Polytechnic Institute is a full board review, and will assess and approve the proposed 
research protocol at one of their regularly scheduled meetings.  
 
Mount Sinai's Human Immune Monitoring Core Shared Resource Facility staff will be responsible for 
storing and processing blood samples.  
 
4) Resources Available to Conduct the Human Research 
Cancer survivors who will receive autologous HSCT for treatment of MM will be recruited from Mount 
Sinai. All patients will be randomly assigned to either the active or comparison condition. We expect to 
recruit 60 patients over the study course. It is estimated that over 100 MM patients are seen at MSH 
annually to receive their first HSCT.  
Research study personnel are very experienced with these types of studies. Research coordinators are 
highly qualified to assume these roles of screening and evaluating subjects, obtaining informed consent, 
analyzing and interpreting complex clinical research data, ensuring accurate and complete compilation of 
subject data, and liaising with the IRB of Protection of Human Subjects issues. 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
5 
Revised 9/2/14 
To ensure that all study personnel are adequately informed about the protocol, all investigators, 
consultants and research coordinators will be required to read the protocol and to review the measures 
and equipment. We will also develop a recruitment script that the research coordinator will practice 
before reaching out to potential participants. 
5) Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a) Recruitment Methods 
 
Potential participants will be identified by Eileen Scigliano, MD, and staff from the group of patients who will 
be undergoing their first autologous HCST and meet the additional inclusion criteria in EPIC. Prior to 
Time 5 
3-months post 
hospital discharge 
 
DAY +100 
 
 
-Actigraph: 72-hours 
-Psychosocial 
questionnaires: once 
during actigraph 72-
hour span 
 
-Blood collection at 
routine clinical visit 
 
60 HSCT 
Patients 
consented 
Time 1 
Baseline 
 
Months-1 Week 
Before Transplant 
 
 
-Actigraph and 
Daysimeter: 72-hours 
-Psychosocial 
questionnaires: once 
during actigraph 72-
hour period 
-Melatonin (overnight): 
Any void after 11pm up 
to 1st AM void during 
actigraph 72-hour span 
Time 2 
Baseline 2 
 
Within 1 Month 
before transplant 
Only if Baseline 1 > 2 
months before 
transplant 
 
-Actigraph: 72-hours 
-Psychosocial 
questionnaires: once 
during actigraph 72-
hour span 
 
Time 3 
Light Intervention 
DAYS (+1) – (+14) 
(0) = day of transplant 
 
-Daily: Light 
Intervention; Actigraph; 
Daysimeter 
-Psychosocial 
questionnaires: Days 
+2, +7 and day 3 of 
engraftment 
-Melatonin (overnight): 
prior to discharge -any 
void after 11pm up to 
1st AM void 
 
-Blood collection: 
Admission and day 3 of 
engraftment 
Time 4 
1-month post hospital 
discharge 
 
DAY +45 
 
 
-Actigraph : 72-hours 
-Psychosocial 
questionnaires: once 
during actigraph 72-
hour span 
 
-Blood collection at 
routine clinical visit 

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
6 
Revised 9/2/14 
autologous HCST, the treating physician will discuss the study to their patient and inform them that they may be 
approached by a RA for participation. Additionally, a letter will be given to the patient, signed by the Director of 
the Multiple Myeloma program, introducing the study, team members, and to seek interest in participation. The 
following week, the RA will approach patients at their medical appointment at MSH in the months leading up to 
transplantation, unless the patient has expressed an unwillingness to participate. Physicians will inform RAs of 
those patients who have asked to not be approached for recruitment. The RC will then describe the study to 
determine their interest in participating, answer questions, and obtain Consent/HIPAA approval. A brief screening 
will subsequently be given to assess patient eligibility based on inclusion/exclusion criteria as listed in b) below. If 
there are any incidental findings during the screening and consent process, the subjects will be put in contact 
with a supervising licensed psychologist.  The research team will look at each subject’s CES-D scores at all 
timepoints to determine if they are at risk for severe depression. The protocol states that if a CES-D score is 
above 16, then the supervising psychologist will call the patient to determine if they need to be referred to 
get professional help regarding potential clinical depression. The BDI-II also can be used as a screener for 
depression. If a subject endorses suicidal ideation (by answering 2 or 3 for question 9, or scores in the 
severely depressed range between 29-63), then the supervising psychologist will also call the patient.  
b) Inclusion and Exclusion Criteria
Our eligibility criteria includes: 
Patients: 

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 will be: 

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
c) Number of Subjects

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
7 
Revised 9/2/14 
For this feasibility study, we will recruit 60 participants drawn from the pool of upcoming HSCT admissions 
to treat MM at the MSH bone marrow transplant (BMT) clinic. Our previous research has demonstrated 
that at least 40% of this group either suffers from or will develop clinically significant fatigue related to 
cancer or its treatment. 
d) Study Timelines 
Total participation in this study is 16-18 weeks, and may vary by hospital admission, length of hospital 
stay, and expediency of returning study related materials.  
Endpoints 
The primary endpoints in the proposed study are: 1) Fatigue as measured by a simple Graphic Rating 
Scale, Multidimensional Fatigue FACIT Fatigue Scale, and The Pittsburgh Sleep Quality Index; 3) 
Depression as measured by the CES-D; 4) Quality of Life measured by the SF-36 scale; 5)Sleep/wake 
activity measured using anactigraph; and 7) Biological variables melatonin and inflammatory markers (i.e., 
IL-1ra, IL-6, MCP-1/CCL2, MIP-1a/CCL3, sTNFr1, sIL-6R, CRP) as obtained via urine and blood analysis.  
 
The secondary endpoints include: 1) the amount of light received by the patient as measured by the 
Daysimeter;2) treatment satisfaction using the FACIT-TS-G scale, and 3) Psychological moderators (e.g., 
emotions, symptom burden) that may affect for whom the treatment is effective. 
 
With regard to safety endpoints, there are no known major risks associated with the use of bright white 
light in the treatment of either fatigue or depression. However, we will monitor those who decide to 
cease treatment because they find the treatment approach unacceptable along with their concerns 
regarding treatment. 
  
e) Procedures Involved in the Human Research 
Approach: We will explore the acceptability, feasibility and potential efficacy of sPI exposure to prevent 
CRF in patients undergoing initial autologous HSCT, as provided during their inpatient hospital stay for 
approximately two weeks following transplant. We will also determine the feasibility of investigating 
biological markers (i.e. melatonin, inflammatory markers) as mediators of the clinical impact on CRF. 
Urine samples will be collected at two timepoints to assess melatonin rhythmicity. Blood samples will be 
collected at four timepoints to assess the inflammatory response in relationship to the light treatment. 
The proposed approach will be informed by procedures Figueiro developed for her recent research on sLE 
treatment in Alzheimer’s patients. Additionally, we will be building on our previously established 
protocols to inform our ability to research sPI treatment. The two teams of investigators will work closely, 
carrying out weekly conference calls and quarterly face-to-face meetings alternating between MSH and 
Rensselaer Polytechnic Institute (RPI). The MSH team will recruit study participants and oversee use of the 
light fixtures, monitoring equipment, assessment scales, and facilitate with Figueiro’s laboratory regarding 
proper storage and analysis of urine samples. MSH will also collaborate with the Mount Sinai's Human 

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
8 
Revised 9/2/14 
Immune Monitoring Core Shared Resource Facility at Mount Sinai to process and analyze blood samples 
to assess and track inflammatory markers. 
Actigraphs will be used to monitor bio-behavioral indicators of circadian rhythms. The Actigraph is 
attached to the non-dominant wrist and measures movement and activity. The Daysimeter is worn 
around the neck and measures light exposure.  
Acuity Lighting Brands will be providing the lighting fixtures in patient rooms at no cost. The fixtures will 
control all emitted wavelengths and provide both treatment and comparison conditions from the same 
fixture, as controlled by the investigators. 
Methods: MM patients who will receive an autologous HSCT as part of their treatment plan will be 
recruited from MSH, and will be randomly assigned to either the BWL or the DWL conditions. Participants 
in both treatment arms will complete baseline 1 assessment at the time they are recruited.  If Baseline 1 is 
completed more than two months before transplant participants will complete baseline 2 approximately 
one month before their transplant.  After the baseline(s) assessment participants will be assessed: (A) 
during the inpatient hospital stay at day of transplant, day + 2, day + 7; (B) engraftment day 3 (most likely 
during week 2-3): (C)  one month after hospital discharge; and (D) three months after hospital discharge. 
Outcome measures include standardized questionnaire measures of CRF, depression, sleep quality, and 
quality of life, as well as analysis of urinary melatonin and blood inflammatory marker levels at both 
outpatient and inpatient timepoints to monitor the biological processes believed to be influenced by sPI. 
This assessment schedule will allow us to evaluate the immediate and post-treatment benefits of the sPI 
treatment.  
The proposed statistical analyses examine a number of related questions. The first consists of a 
comparison of the impact of the sPI exposure intervention to a comparison condition on CRF, depression, 
sleep quality, circadian rhythmicity, and quality of life using both the self-report and objective outcome 
measures (i.e. actigraphy data) in MM patients undergoing autologous HSCT. The second will examine the 
possible mediating role of depression, sleep quality, circadian activity rhythms, and fatigue on the effects 
of sPI. Lastly, the third will assess the feasibility and acceptability of an sPI intervention, actigraphy, urine 
melatonin analysis, and light exposure monitoring during HSCT.  We will also look at possible co-
moderators that may influence for whom the treatment works as defined by the list of additional 
measures we have included. In addition, we will explore whether the light treatment improves fatigue and 
depression through biological mediators analyzed in blood, i.e. inflammatory markers.  
Please see the Data Safety and Monitoring Plan in section 5h for procedures taken to lessen the 
probability or magnitude of risks.  
Data about subjects will be collected from medical charts, urine samples, blood samples, questionnaires 
that the participants will fill out, and output from the equipment (i.e., Actigraph and Daysimeter data).  

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
9 
Revised 9/2/14 
If there are any adverse events during the screening and consent process, the study participants will have the 
option to be put in contact with the a licensed clinical psychologist. The suicidality protocol will be in place 
throughout the entire study. It will be in the judgment of the consenting professional and/or as per medical 
record to determine if a patient may have severe psychopathology or cognitive impairment likely to interfere with 
the participation or completion of the protocol or ability to provide meaningful information. In this case, 
professional will decide not to include potential participant in the study. 
The following questionnaires will be completed during the study: 
Background Measures: 

Background Information Questionnaire – Socio-demographic data regarding gender, age, ethnicity,
religion, income, marital status, and employment status will be gathered during the screening
assessment and any changes in information will be gathered at the follow-up assessments. We will
assess co-morbid medical conditions and current prescription sleep-related and non-sleep-related
medications.

Chronotype (MEQ) – We will collect data on baseline circadian predispositions using the Morningness-
Eveningness Questionnaire, a 19-item self-rated survey designed to measure whether a person’s peak
alertness is in the morning or the evening. Takes approximately 2 minutes to complete.
Credibility Measures: 

Credibility/Expectancy Questionnaire – This questionnaire will ask whether the patient feels the light
box is a useful and/or effective treatment for CRF.
Sleep and Fatigue Measures: 

Sleep Log – The sleep log will ask the participant to note what time she/he went to bed, what time
she/he got out of bed, any times the Daysimeter and/or Actiwatch was removed, and whether she/he
spent any time sitting very still (such as at the movies). The sleep log will be used to help edit
actigraphy data.

FACIT-Fatigue Scale – 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

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
10 
Revised 9/2/14 
Information System (PROMIS) initiative. Cella (personal communication) has indicated that a FACIT-
Fatigue score equal to or less than 33 constitutes clinically significant fatigue. 

Fatigue Line Scale – Simple numeric graphic rating scale, marked on a line numbering 0-100. Replaces
the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.

Multidimensional Fatigue--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 – 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).

SF-36 scale - 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.
Depression Measures: 

CES-D (Center for Epidemiologic Studies Depression Scale) – 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.
Emotion Measures: 

PANAS – 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
imensions, 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

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
11 
Revised 9/2/14 
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). 
Symptom Measures: 

Brief Symptoms Inventory-18 (BSI-18) - 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).
Medical tracking form - Medical data will be gathered through medical chart review and interview including 
comorbid and excluded medical conditions, medical information related to transplant, current prescription sleep-
related and non-sleep-related medications, history of treatment with light therapy, and remaining exclusion 
criteria. During the final timepoint, research coordinators will check the participant’s medical chart using the 
medical tracking form and enter updated relevant health information into a password protected file.  
f) Specimen Banking
Urine Samples – 
All 60 participants will be assessed using biological measures (via urine samples) at two points. Samples 
will be collected once during baseline 1 before their transplant admission and once during inpatient 
treatment (on Day Three of engraftment).. 
Outpatient urinary samples will be collected at home by the participant, according to the provided 
timetable. Exact times will be noted on the samples in case of any variance in sample timing. Participants 
will be instructed to collect any void after 11pm up to 1st AM void overnight during the 72-hour span of 
wearing the actigraph and daysimeter at baseline, and then during hospitalization prior to discharge. 
Urinary sample containers will be provided by the study team. Collection time of samples will be written 
on the outside of the containers by participants. Samples will be refrigerated and mailed directly to RPI 
LRC Biomarker Lab for analysis using a pre-paid shipping label provided by RPI. 
Biological samples collected in the hospital will be gathered according to regular BMT procedures by a 
registered nurse or physician, and processed as with at-home collections. 
Blood samples – 

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
12 
Revised 9/2/14 
Research related blood draws will be performed at four time points corresponding with routine clinical 
blood draws: First blood draw upon admission to the hospital, at the third day of engraftment (T3e, at the 
clinical visit about one month post-transplant (T4) and at the clinical visit about three months post-
transplant (T5). Blood will be collected at MSH by a licensed phlebotomist. At each time point 16.7mL 
(approximately 3.5 teaspoons) will be collected in red top SST tubes, yellow top ACD tubes, and blue top 
Tempus tubes, delivered within 30 minutes, and processed immediately in the laboratories of Mount 
Sinai's Human Immune Monitoring Core Shared Resource Facility according to established blood 
processing protocols. 
g) Data Management and Confidentiality
All data obtained will be placed into individual research participant folders and stored in a locked file 
cabinet in the department of Oncological Sciences. Only study personnel will have access to this file 
cabinet. All folders and data pertaining to individual subjects will be identified only by a code number and 
only the PI (Redd) and Co-investigator (Valdimarsdottir) the research coordinators will have access to 
electronic file that links the numbers to patient identities. Upon completion of the study, the file that links 
patients to the codes will be deleted.  
Data sent between RPI, Mount Sinai, and the participants will be shipped via UPS. Patient names and 
dates of birth will not be included in mailed data to protect patient privacy. Mailed data will only be 
identified with study-ID numbers. RPI will be assessing melatonin levels, and will not receive any 
protected health information (PHI) other than the results of the biological assessments as well as 
assessments taken over the course of the study. 
Data from any web-based assessment tools will be accessible to research study team using password 
protection and will only be identified by participant ID number. Paper files and printouts of assessment 
scores will be kept in a locked cabinet with access only by authorized project research staff. The use of 
email will be in accordance with MSH policy (i.e. secure email, obtaining consent from subject to send 
email, etc.). 
Urine and blood samples will be marked only by study ID number and no other identifying information. 
Data Analysis: 
Descriptive statistics will be calculated both for the entire group and separately for each treatment group. 
T-tests and Fisher’s exact tests will be used to assess group differences at baseline for possible 
confounders (i.e., demographic variables, clinical characteristics, and medications). Any variables showing 
differences between the two groups will be used as covariates in subsequent analyses. Since there is no 
known seasonality effect to measures of fatigue or to measures of sleep, which are our main outcome 
measures, seasonality will not be controlled in these analyses. For the primary outcome (Fatigue),   the 
secondary outcomes (Depression, Sleep, Circadian Activity Rhythms, melatonin (exploratory), and Quality 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
13 
Revised 9/2/14 
of Life), hierarchical random effects linear mixed models will be employed for Aims 1 and 2 using MIXED 
with repeated measures. Besides time (linear and possibly quadratic trends to allow for possible nonlinear 
trends), any covariates identified in the preliminary analyses and intervention group will be assessed in a 
fixed effects model. Each model will also include a random intercept. Post-hoc comparisons will be Tukey-
adjusted. Since there are multiple secondary outcomes, the p-values will be Sidak adjusted for correlated 
multiple comparisons. Any variations in length of hospital stay (i.e., length of intervention) will be used as 
a covariate in all analyses. This is highly unexpected since 90% of ASCT patients are hospitalized for 14 
days. In the Analysis of Aim 2, we will establish that the treatment is a significant predictor of the primary 
outcome (CRF) as well as the hypothesized mediators. Next, we will first examine the role of each of the 
mediators of the effects of sPI on CRF by introducing each individually into the equation which contains 
the time variable, the treatment main effect, and the time by treatment interaction. Each mediator which is a 
significant predictor of CRF in this equation will then be combined with any other significant mediating 
predictor of CRF into a single equation. We predict the introduction of each significant mediator will result 
in the decrease in the significance of the time by treatment interaction effect on CRF. However, the more 
important test of the mediating role by any variable will depend on the statistical significance of the indirect 
path from treatment to mediator and from mediator to the outcome. Following procedures suggested by 
Shrout and Bolger (2002), 1000 bootstrap samples will be employed to determine the significance of each 
indirect path.50 Power: It is difficult to discuss power for Aim 1 and Aim 2 since there is no directly 
relevant past research. As a consequence, one of the goals of this project is to obtain estimates of the effect 
sizes that will eventuate from our proposed analyses. Although unknown at the moment, these effect sizes 
can guide decisions regarding sample sizes for a larger scale grant. In the interim, there are three lines of 
research that may provide some guidance.  The first involves the work of Ancoli-Israel, who investigated 
the effects of light treatment on fatigue experienced by women undergoing chemotherapy for breast 
cancer.9 Using her results, we calculated power for a repeated measures design with an autoregressive lag 1 
structure and autocorrelations ranging from 0.40 to 0.60. With alpha equal to 0.05 and a sample size of 30 
patients per group, power ranged between 0.96 and 0.98. We followed a similar approach using Redd’s 
results but focusing only on MM survivors of ASCT.10 In this case, power was 0.99 for autocorrelations 
ranging between 0.40 and 0.60. However, the latter results must be treated cautiously because these 
calculations were based on a very small sample (N = 17 survivors). Using the same small sample, our 
repeated measures analysis of depression indicated that the time by treatment condition interaction was 
marginally significant (p = 0.0568). The F-ratio for this interaction yielded an eta coefficient of 0.48 which 
would be considered moderately strong following Cohen‘s criteria.49 We hypothesize that the interaction 
effect would have been significant had the sample size been larger as is being proposed in this study (N = 
60). Because of the very small survivors sample and the variability of our indicator of circadian activity 
rhythms (the f-statistic), the Mixed program did not converge and it was not possible to obtain a power 
estimate for this outcome. The third line of research that is germane to power in the proposed pilot study 
was conducted by Sim and Lewis who applied the UCL approach and found that a pilot sample of n => 55 
would minimize the overall sample size for small to medium standardized effect sixes (0.2-0.6). 
 
References: 
·         Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations 
of precision and efficiency. J Clin Epidemiol 2012; 65: 301–308. 

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
14 
Revised 9/2/14 
·
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial
to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. 
Julious SA, ed. Statistical Methods in Medical Research. 2016;25(3):1057-1073. 
Urine samples will be analyzed for melatonin excretion by RPI according to their laboratory protocol. 
Blood Samples will be analyzed for a panel of inflammatory markers according to Mount Sinai's Human 
Immune Monitoring Core Shared Resource Facility protocols. 
Data, Safety, and Monitoring Plan 
The following plan addresses the four essential elements noted in NCI’s 2001 outline: “Essential Elements 
of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute.” 
1. Monitoring the progress of trials and the safety of participants.
The proposed research is a low-risk behavioral trial. Study staff will be available to participants who have 
any difficulty with their equipment or any unexpected reaction during the intervention period. Study staff 
will be required to report all serious adverse events (SAEs) to the Mount Sinai IRB according to policies 
and procedures outlined by that body. Study staff members are also responsible to report all SAEs to the 
study PI as well. As per Icahn School of Medicine at Mount Sinai’s IRB policies, the study PI is required to 
notify the IRB promptly of any unanticipated problems involving SAEs and risks to subjects or others that 
occur. The study staff PIs will monitor the progress of the trial and safety of participants on an ongoing 
basis. The procedures of this study will ensure discussion and reporting of all possible outcomes including 
adverse events. If the adverse event is due to the intervention and is unexpected, the PI will draft a safety 
report and send a copy to the Mount Sinai IRB. The IRB committee will serve as an objective review 
mechanism. This policy/procedure means that any potential conflict of interest inherent in the PI being 
the sole reviewer of SAEs is avoided. 
We will use screening procedures from our prior grants to assess depression/suicidality. If risk of 
suicidality or severe depression is revealed, a licensed clinical psychologist in New York State, will contact 
the participants the same day, taking emergency steps and making referrals as needed.  
2. Plans for assuring adherence with requirements regarding the reporting of adverse events
(AEs). 
All serious AEs (e.g., medical occurrences resulting in either hospitalization or death) that occur during the 
study defined by the given protocol, regardless of the relation to the research, must be reported to the 
IRB by telephone, e-mail or fax within 24 hours of the investigator’s awareness of the occurrence of the 

Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
Principal Investigator: 
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
15 
Revised 9/2/14 
event. The PI will report SAEs to the Mount Sinai IRB and will disseminate information to other sites or 
agencies as necessary. These safety reports are a written account of an SAE determined by the PI to be 
both related to the psychological treatment under investigation and unexpected in nature. Serious AEs 
will be summarized annually in the IRB application for continuation or termination of research. 
All expected non-serious AEs that occur at a greater frequency or severity than anticipated and all 
unexpected non-serious AEs will be reported to the Mount Sinai IRB within 15 working days of the PI 
becoming aware of the event. Adverse events that will be reported include suicidal ideation, which will be 
monitoring at each check-in. These AEs are also summarized annually in the IRB application for 
continuation or termination of the research.   
3. Plans for assuring that any action resulting in a temporary or permanent suspension of an
NCI-funded clinical trial is reported to the NCI grant program director responsible for the grant. 
The Director of the Grants and Contracts Office at Icahn School of Medicine at Mount Sinai will provide 
prompt written notification of any action resulting in a temporary or permanent suspension of this 
protocol to the NCI grant program director responsible for the grant. 
4. Plans for assuring data accuracy and protocol adherence.
Data that will be collected from study participants will be in the form of self-report measures, actigraphy 
data, urine collection, and information from Daysimeter light monitors. These measures will generate 
information concerning: 1) fatigue; 2) sleep patterns; 3) depression; 4) biological mediators of the 
investigated symptoms; 6) general quality-of-life and information on common cancer treatment-related 
sequelae; and 5) socio-demographic and medical variables. The study PI and research team will assess 
data from sleep journals and Actigraphs as indicators of protocol adherence. The research team will have 
conference calls as stated above to monitor any adherence or accuracy problems that may arise in the 
course of the study. To ensure the validity and integrity of study data, a research coordinator will be 
blinded to the treatment assignment. The blinded research coordinator will oversee data management 
responsibilities (e.g., data entry and data checking) while the unblinded research coordinator will oversee 
the active and comparison light intervention. All research coordinators and Meschian will discuss data 
accuracy and management issues with the study PI. RAs will be in close communication with RPI 
investigators to ensure proper data analysis. 
h) Provisions to Monitor the Data to Ensure the Safety of Subjects
The safety of subjects will be assured by constant monitoring of study protocols by: 
MSH Principal Monitor, Study PI: 
Last Name: Redd 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
16 
Revised 9/2/14 
First Name: William 
Academic Title: Professor of Psychology 
Department: Oncological Sciences 
Mailing Address: 
, New York, NY 10029-6514 
Phone: 212-659-5515 
Fax: 212-849-2566 
E-mail: William.redd@mssm.edu 
 
MSH Additional Monitor, Team Members: 
Last Name: Valdimarsdottir 
First Name: Heiddis 
Academic Title: Assistant Professor 
Department: Oncological Sciences 
Mailing Address: 
, New York, NY 10029-6514 
Phone: 212-659-5579 
Fax: 212-859-2566 
E-mail: Heiddis.valdimarsdottir@mssm.edu 
 
 
The proposed intervention is low-risk, and has been heavily informed by prior investigation by Dr. Redd 
and Valdimarsdottir . They are familiar with the intervention and its potential side effects, and will be able 
to provide consistent oversight of the project. Coherence of the collected data will be assessed on a yearly 
basis, while treatment compliance, adverse events, and patient expectancy/blinding will be assessed once 
every three months by Redd, Valdimarsdottir and research coordinators. They will inform and alter study 
methods based on this information. Data management is described in section h above. If the study is put 
on hold, IRB will be informed of the change in study timeline. 
 
i) Withdrawal of Subjects 
 
Patients will be allowed to withdraw from the research at any time. They will also be allowed to skip any 
questions or questionnaires.  
6) Risks to Subjects 
There always exists the potential for loss of private information; however, all possible precautions will be 
set in place in order to prevent loss of confidentiality. See section 5h. 
Other risks or side effects may include: 
 
Headache 
 
Nausea 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
17 
Revised 9/2/14 
 
If used incorrectly (e.g. such as staring directly into the light) it may cause eye discomfort or eye strain 
 
Likelihood of Harm: There will be minimal risk to the participants. Light levels will be much lower than 
those experienced when subjects are outdoors during a bright sunny day. The subjects will not be exposed 
to ultraviolet radiation.   
 
Light levels used in this experiment are lower than the levels produced by typical bright-light boxes (which 
is 10,000 lux) or produced at midday in a clear sunny day (about 100,000 lux). Using hazardous light 
exposure levels specified by the American Conference of Government Industrial Hygienists,  one would 
need to be exposed to this light source for more than 10 hours continuously before it becomes a risk. 
 
Major research has not found increased risks of using light therapy for most major eye diseases. However, 
in the unlikely event the participant feels that the light is affecting their eyes or vision, they will be advised 
to contact the research team immediately. 
 
Previous research suggests that light therapy can improve the effectiveness of some antidepressant drugs.  
No evidence to date suggests that it decreases the effectiveness. If the participant is concerned about 
this, they will be advised to consult their physician.   
 
Completing questionnaires during the study may cause some distress or discomfort, however, past 
research has shown that such distress is usually minimal and transient. 
 
Wearing the light monitor (Daysimeter) and/or activity monitor (Actigraph) may cause discomfort. If this 
discomfort is unmanageable, the participant will be asked to  report such discomfort to the research 
coordinator. 
 
Risks associated with blood draws: There is a minimal risk of pain, bruising, swelling, dizziness, or 
infection when blood is drawn from your arm. Some people feel dizzy or may faint during or after 
a blood draw. To minimize risk, blood for research purposes will only be drawn at the same time 
as routine clinical blood draws. 
 
7) Provisions for Research Related Harm/Injury 
 
The proposed project is a low-risk behavioral study. We will inform participants during the consent 
process that there is a chance that they will experience potential side effects of light therapy, e.g., sleep 
disturbance, headache, eyestrain, nausea, and hyperactivity, and in very rare instances, photic 
maculopathy, photophobia, hypomania, and suicidal ideation/suicide attempts have occurred (in those 
with pre-existing severe depression). They will be informed that such side effects are usually minimal if 
the light is positioned correctly and when they do occur, resolve within a few days. During the course of 
the protocol, if after 3 days the side effects persist, we will withdraw them from the study. Additionally, 
their care provider at the BMT clinic will be notified and refer the patient to a specialist if necessary. We 
will also follow up with those who discontinue the study due to side-effects and refer them to their care 
provider should symptoms persist even after discontinuation of the light exposure. Medical concerns will 
be billed according to other procedures occurring during hospitalization, since this is an inpatient study. 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
18 
Revised 9/2/14 
 
We will also inform patients during the consent process that there is a chance participants will feel some 
distress or discomfort as a result of answering some questions asked during the study or completing the 
neuropsychological assessment. Participants will be assured that they can refuse to answer any questions 
or withdraw from the study at any time without penalty. Participants’ psychological symptoms will be 
monitored throughout the study. If any participant expresses severe suicidal ideation, evidences acute or 
emergency psychiatric symptoms, or asks for psychiatric care, a referral will be made. The RA will be 
trained to identify participants who may be experiencing such problems and discuss them with Meschian 
(a Ph.D.-level licensed clinical psychologist). The PI will be notified of any adverse participant reaction and 
psychiatric referral will be made, if necessary. If additional psychiatric care is warranted, participation in 
the study will be discontinued. Any participants presenting with physical complaints will be referred to 
their oncologist for evaluation so that the oncologist can rule out organic causes and/or make additional 
referrals, if needed. Participants who are assessed as having significant cognitive impairment and 
significant sleep dysfunction will also be referred to their oncologist for evaluation. 
 
8) Potential Benefits to Subjects 
Subjects may feel less fatigued after their transplant by undergoing daily sPI as a feature of their inpatient 
treatment. Subject fatigue may return after they stop sPI at the time of their medical discharge.  
9) Provisions to Protect the Privacy Interests of Subjects 
 
All study data collected will be also stored electronically. The data will be stored on a MSH network drive, 
accessible only to the PI and members of the research team. The data will be password protected. During 
data summarization and analysis, individual participants will be identified by code number only. No data 
identifying individual participants will be published or disclosed to third parties without prior consent of 
the participant. A list matching names with code numbers will be kept in a separate computer file and 
folder from the one where the data is stored.  
 
If a participant agrees to participate in the study, all questionnaires will be labeled with the participants’ 
study ID number, not their name and not their medical record number. Subjects will be informed that 
they can choose to not answer any questions that make them feel uncomfortable. Subjects will need to 
give study personnel their home addresses to which the study materials and questionnaires can be sent. 
This data will be kept private on the MSH network drive in a password protected spreadsheet. Subjects 
will mail back all study materials in a pre-paid envelope with an ID number and an MSH address as the 
return address.  
 
Participants will provide the study team with a telephone number on which we can call them to 
administer questionnaires and help with any issues. If we need to leave a message, we will ensure that no 
confidential information or any information about the patient’s study participation is revealed. 
 
 
Subjects can withdraw from the study at any time or not answer questions they do not wish to address. 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
19 
Revised 9/2/14 
 
 
10) 
Economic Impact on Subjects 
We do not expect the subjects to incur any foreseeable costs through their participation in our study. We 
will be shipping all relevant study materials to each subject’s home at our expense. Lights, actigraphs, and 
daysimeters will be provided to clients at no cost during the study. Blood draws at Mount Sinai will be 
scheduled on days of routine clinical visits, eliminating any additional transportation or cost to the 
subject. 
 
11) 
Payments to Subjects 
Study participants will receive a $25 reimbursement for each time-point (study is divided into five time 
points – baseline 1, baseline 2, hospital stay, 1-month post and 3-months post). For a participant who 
completes the entire study this will come to a total of $125 paid in two check installments of $50 (or $75 
for the first installment if  baseline 2 administered). This payment plan was established because subjects 
will not need to come into Mount Sinai specifically for the research study. Therefore, it will be more 
practical to request and send participants two checks, rather than five/six different checks throughout the 
duration of the study.   
12) 
Consent Process 
Informed consent will be obtained from participants in person before the collection of any data - Eligible 
patients will be contacted during their initial HSCT consult visit (time to transplant varies between 
patients) to MSH and given information on the study. The study coordinator will then administer the 
informed consent process. The RC will: describe the study, give the subject’s time to read the consent 
form, allow the subjects to discuss their decision with whomever they like, allow the subjects to digest the 
information, and allow the patients to ask the member of the study team any additional questions they 
might have. 
 
All consented participants will be informed about study procedures, extent of participation, and potential 
risks and that their participation is voluntary and will not jeopardize their relationship and participation in 
any activity they conduct or care that they receive at MSH. Participants will also be provided with a 
telephone number where they can call if they have any questions or concerns about the study or the 
consent form. 
 
13) 
Process to Document Consent in Writing 
We will be asking participants to sign the standard PPHS consent template. 
14) 
Vulnerable Populations 
Indicate specifically whether you will include (target) or exclude each of the following populations: 

 
Protocol Name: 
Systematic 
Programmed 
Illumination 
of 
Hospital 
Rooms 
to 
Prevent/Reduce Cancer-Related Fatigue during Autologous Stem Cell 
Transplantation for Multiple Myeloma 
 
Principal Investigator:  
William H Redd, Ph.D; William.redd@mssm.edu 
Primary Contact 
Name/Contact Info: 
 Laura Guttentag, 212-659-5547, Laura.guttentag@mssm.edu 
Date Revised: 
8/15/2019 
Study Number: 
IF# 2517160 HS# 15-00777 GCO#: 15-2009 
 
20 
Revised 9/2/14 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, 
teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 
All information will be stored and managed by Redd at MSH. Actigraphs, Daysimeters, sampling materials, 
and questionnaires will be mailed between the participants and the study team at MSH. No identifying 
information will be included on the equipment and questionnaires will only include code numbers. MSH 
will send RPI the Actigraph and Daysimeter data via secure email. Blood samples will be analyzed at 
Mount Sinai's Human Immune Monitoring Core Shared Resource Facility. Urine samples will be analyzed 
at the laboratory at RPI LRC. Samples will only be identified by participants' study-ID numbers.  
16) 
Community-Based Participatory Research 
N/A 
17) 
Sharing of Results with Subjects 
If patients request information about the study results (i.e., whether light exposure was clinically effective 
in reducing cancer related fatigue), we will provide them with a copy of the publication that details the 
results. 
18) 
External IRB Review History 
N/A 
19) 
Control of Drugs, Biologics, or Devices 
Devices will be mailed to and from subjects via UPS. They are water resistant, and require no special care 
or attention from participants.