Feasibility of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors
Phase: NA
Conditions: Fatigue, Sleep Disturbance, Circadian Dysregulation
Sponsor: State University of New York at Buffalo

Cover Page for Protocol, Statistical Plan and ICF 
 
Official Title: 
Bright Light Therapy to Improve Sleep Continuity 
Disturbances in Lung Cancer Survivors. 
NCT number: 
NCT02954809 
Document Type: 
Study Protocol 
Date of the 
Document: 
01/29/2017 
 

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
PROTOCOL TITLE: Bright Light Therapy to Improve Sleep Continuity Disturbances in 
Lung Cancer Survivors. 
Page 1 of 36 
 
 
INSTRUCTIONS: Complete Research Protocol (HRP-503) 
• Depending on the nature of what you are doing, some sections may 
not be applicable to your research.  If so, you must provide the 
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example, most behavioral studies would answer all questions in 
section 30 with words to the effect of “drugs and medical devices 
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PROTOCOL TITLE: 
 
Bright Light Therapy to Improve Sleep Continuity Disturbances in Lung 
Cancer Survivors. 
  
 
PRINCIPAL INVESTIGATOR: 
Name Grace Dean 
 
Department School of Nursing 
Telephone Number (716) 829-3235 
Email Address gdean@buffalo.edu 
 
VERSION NUMBER: 
 DATE:01/29/2017 

 
Page 2 of 36 
Revised: November 15, 2016 
Include the date of submission or revision. 
 Grant Applicability:01/29/2017 
Describe whether or not this protocol is funded by a grant or contract and if so, 
what portions of the grant this study covers. 
This protocol has received an Oncology Nursing Society Foundation 
Grant in the amount of $25,000 for the years 2015-2017. The grant covers 
the entire study. 
 
 

 
Page 3 of 36 
Revised: November 15, 2016 
Table of Contents 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Background .............................................................................................................. 4 
3.0 
Inclusion and Exclusion Criteria ............................................................................ 11 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) ............................ 13 
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only).......................... 13 
6.0 
Multi-Site Research (Multisite/Multicenter Only) ................................................. 13 
7.0 
Study Timelines ..................................................................................................... 14 
8.0 
Study Endpoints ..................................................................................................... 14 
9.0 
Procedures Involved ............................................................................................... 15 
10.0 Data and Specimen Banking .................................................................................. 18 
11.0 Data Management .................................................................................................. 18 
12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects ....................... 21 
13.0 Withdrawal of Subjects .......................................................................................... 22 
14.0 Risks to Subjects .................................................................................................... 23 
15.0 Potential Benefits to Subjects ................................................................................ 23 
16.0 Vulnerable Populations .......................................................................................... 24 
17.0 Community-Based Participatory Research ............................................................ 24 
18.0 Sharing of Results with Subjects ........................................................................... 25 
19.0 Setting .................................................................................................................... 25 
20.0 Resources Available ............................................................................................... 26 
21.0 Prior Approvals ...................................................................................................... 28 
22.0 Recruitment Methods ............................................................................................. 28 
23.0 Local Number of Subjects ..................................................................................... 29 
24.0 Confidentiality ....................................................................................................... 29 
25.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 30 
26.0 Compensation for Research-Related Injury ........................................................... 31 
27.0 Economic Burden to Subjects ................................................................................ 31 
28.0 Consent Process ..................................................................................................... 31 
29.0 Process to Document Consent in Writing .............................................................. 35 
30.0 Drugs or Devices.................................................................................................... 35 
 

 
Page 4 of 36 
Revised: November 15, 2016 
1.0 
Objectives 
 
• Assess the effect of morning bright light versus dim light therapy (control) 
on fatigue and sleep continuity disturbance in lung cancer survivors.  
• Predict efficacy to morning bright light therapy versus dim light therapy 
(control) on fatigue and sleep continuity disturbance in lung cancer 
survivors.  
• Evaluate, in a preliminary way, the extent to which time from treatment 
(as a proxy iatrogenic effects), sleep homeostatic “de-prime” (mismatch 
between sleep opportunity and ability), and circadian factors (phase and 
amplitude) predict illness severity and treatment response.  
 
 
1.1 
Hypothesis  
 
Hypothesis 1: Subjects in the Bright Light Treatment group will exhibit 
significant improvements as compared to Dim Light Treatment in fatigue, 
sleep and circadian activity rhythms. 
Hypothesis 2: Subjects typed during baseline as having circadian dysrhythmia 
using actigraphy (circadian phase and amplitude abnormalities) will be 
significantly more likely to exhibit treatment responses.  
 
 
2.0 
Background 
2.1 Describe the relevant prior experience and gaps in current 
knowledge. 
 
Fatigue and sleep disturbance are common in cancer survivors (Berger et 
al., 2009; Roscoe et al., 2007; Pachman et al., 2012). Fatigue is reported in 
up to 97% of patients receiving cancer treatment and in 34% of cancer 
survivors (Goedendorp et al., 2013; Kapo et al., 2015). Sleep disturbance 
is reported in up to 88% of patients receiving cancer treatment and 56% of 
cancer survivors (Ancoli-Israel, 2009; Barsevick et al., 2010; Berger et al., 
2009; Palesh et al., 2010). When compared to other patients diagnosed 
with cancer, patients with lung cancer have more than double the 
prevalence of fatigue and sleep disturbance (Davidson et al., 2002; 
Gooneratne et al., 2007).  
  

 
Page 5 of 36 
Revised: November 15, 2016 
The assessment of fatigue is common in cancer research. Less common is 
the evaluation of sleepiness and sleep disturbance. While related, these 
three phenomena may have distinct etiologic pathways and require (or best 
respond) to different treatment approaches. Fatigue refers to mental and 
physical weariness and exhaustion, where performance is compromised. 
Sleepiness is identical to fatigue with one critical difference: patients are 
also vulnerable to falling asleep at inappropriate times and places. Sleep 
disturbance is a generic term for all sleep complaints and disorders 
including sleep continuity disturbance (i.e., difficulty falling and staying 
asleep), respiratory disturbance during sleep (e.g., sleep apnea and 
nocturnal hypoxia/hypoxemia), and/or motor disturbances during sleep 
and parasomnias. For this study, sleep disturbance will specifically refer to 
sleep continuity disturbance (SCD) and respiratory disturbance (RD) 
during sleep. 
The rather singular focus on cancer related fatigue and the assumption that 
this occurs with cancer treatment, suggests that fatigue should abate either 
with the response to, and discontinuation of, treatment. As noted above, 
this is largely true for fatigue (~60% reduction from treatment to 
survivorship) but less true for sleep disturbance (30% reduction from 
treatment to survivorship). In both cases significant, the survivorship 
prevalence is high and is comparable to, or exceeds, the population 
general population rates. The lack of resolution in both cases suggests that 
additional treatment is necessary, particular during survivorship. The 
question is “where and how to follow-up?” In the absence of mature data 
on sleepiness in cancer survivors, the higher prevalence rates of sleep 
disturbance suggests that this may be the best first therapeutic target. 
Given, a large literature on circadian rhythm disturbance in cancer patients 
and survivors (Golombek et al., 2013), this suggests that chronobiologic 
treatments in general, and Bright Light Treatment (BLT) in particular is an 
ideal option.  
Preliminary testing of BLT has been conducted in a variety of cancer 
patients to improve cancer-related fatigue, but not in patients with lung 
cancer. Additionally, the efficacy of BLT on improving sleep continuity 
disturbances, daytime functioning and quality of life has not been assessed 
in lung cancer survivors. Accordingly, we proposed to conduct a 
preliminary study of the effects of BLT in patients who are lung cancer 
survivors. 
 
 
2.2 Describe any relevant preliminary data.  
The multidisciplinary team assembled for this project has conducted three 
studies that involved lung cancer survivors (ref). These studies established 
that lung cancer survivors (n=76) experienced middle insomnia (i.e. 
difficulty maintaining sleep) and determined that patients receiving 

 
Page 6 of 36 
Revised: November 15, 2016 
chemotherapy for lung cancer (n=50) had early (i.e. difficulty falling 
asleep) and middle (difficulty staying asleep) insomnia (Gooneratne, Dean 
et al. 2007, Dean, Finnell et al. 2010). Our most recent mixed method, 
longitudinal study with 4 measures over 6-months (n=29) found that 89% 
reported the occurrence of fatigue and 67% reported fatigue was persistent 
across treatment. In addition, poor sleepers (72%) had less activity, 
weaker rhythmicity and more phase delay compared to good sleepers 
before and during treatment for non-small cell lung cancer. Acrophase, 
where peak activity in a 24-hour period occurs, was significantly 
negatively related to FACT-L physical and functional subscales and total 
scores indicating later peak activity is related to poorer QOL. These 
findings support the occurrence of fatigue, sleep continuity disturbance 
and circadian activity rhythm disturbance in lung cancer survivors and 
support for the rationale for testing BLT. 
 
2.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how 
will it add to existing knowledge. 
The guiding theory for this proposal is the Two-Process Model of Sleep 
Regulation, a leading theory of sleep regulation (Borbely 1982). It 
suggests that sleep occurs when the homeostatic drive to sleep (process S) 
approaches an upper threshold, and awakening from sleep occurs when 
process S reaches a lower threshold. The need to sleep increases the longer 
you are awake. The second process, process C, is a sinusoidal rhythm that 
fluctuates across the 24hour day and is driven by a clock-like mechanism 
in the brain (suprachiasmatic nucleii). The circadian system communicates 
time of day (light and dark cues from the retina) and thereby regulates the 
transition from wakefulness to sleep and the transition from sleep to 
wakefulness. For example, in an individual awake during the day and 
sleeping at night, the circadian process C is highest from 3am to 5am, 
when it is very difficult to overcome the need to sleep and is lowest from 
4pm to 6pm, where sleep propensity is minimal. The circadian process C 
and the homeostatic process S both contribute to sleep consolidation. The 
interaction between these two processes forms the basis for a remarkably 
standardized period of sleep at night and a consolidated period of 
wakefulness throughout the day. However, mechanisms that oppose or 
enhance process S or process C can have a significant effect on the timing, 
duration and structure of sleep as well as daytime functioning.  
In the context of cancer and cancer survivorship, the question is “are one 
or both of these processes” altered by the disease, its treatment, or by 
strategies adopted by patients to cope with and/or manage their fatigue and 
sleep disturbance. Homeostatic dysregulation may occur as a result 
curtailed time awake during the day and increased time in bed at night. 
The trigger for these behavioral changes (which de-prime sleep 
homeostasis) may be the patient’s sense of fatigue (which may occur with 

 
Page 7 of 36 
Revised: November 15, 2016 
the disease process or as a result of treatment) and signal to the patient that 
they need more sleep when what they are experiencing is fatigue and not 
sleepiness. The end result is a mismatch between sleep ability and sleep 
opportunity and that this results in sleep continuity disturbance, daytime 
sleepiness, and an exacerbation of extant daytime fatigue. Circadian 
dysregulation may also occur because of altered sleep wake schedules 
and/or to changes in how much and when the patient is exposed to bright 
light (Berger and Farr 1999, Berger, Farr et al. 2007, Ancoli-Israel, 
Rissling et al. 2012). Further, the circadian system may be dysregulated 
owing to intrinsic factors. Cancer, or its treatment, may directly alter core 
body temperature rhythms or amplitude, suppress, enhance or phase shift 
melatonin secretion, and/or fundamentally alter and dysregulate other 
neuroendocrine functions that have a circadian periodicity and influence 
fatigue, sleepiness, and sleep (Armaiz-Pena, Cole et al. 2013).   
Most cancer research on fatigue (and to a lesser extent sleepiness and 
sleep disturbance) has focused on circadian dysregulation. To date it has 
been found that cancer patients exhibit circadian rhythm 
desynchronization of cortisol and melatonin (Dogliotti, Berruti et al. 1990, 
Dolberg, Hirschmann et al. 1998, Davis, Mirick et al. 2001), disrupted 
phase-delayed activity acrophase (Ancoli-Israel, Rissling et al. 2012, 
Berger, Hertzog et al. 2012), lower circadian quotient (Levin, Daehler et 
al. 2005, Berger, Hertzog et al. 2012) and that cancer survivors exhibit 
flattened biomarkers of circadian rhythms (Bower, Ganz et al. 2005, 
Bower 2006, Bower, Ganz et al. 2006, Bower 2007, Bower, Ganz et al. 
2007). These data strongly suggest that circadian factors are associated 
with fatigue and sleep-wake disturbances (Levin, Daehler et al. 2005) and 
that chronobiologic interventions may be useful for the management of 
cancer related fatigue, sleepiness, and/or sleep disturbance (Ancoli-Israel, 
Rissling et al. 2012, Berger, Hertzog et al. 2012, Redd, Valdimarsdottir et 
al. 2014). Circadian rhythm disturbances are managed according to the 
specific type of disorder, but three common therapies are briefly 
discussed: Chronotherapy, Melatonin Therapy, and Bright Light Therapy.   
Chronotherapy is a behavioral intervention to progressively re-align one’s 
biologically based and preferred sleep phase with standard clock time 
(Eckerberg, Lowden et al. 2012). Melatonin Therapy entails the 
administration of exogenous melatonin (melatonin is also a neurohormone 
produced in the pineal gland) to exert chronobiotic effects (Burgess, Savic 
et al. 2003, Burgess and Fogg 2008, Burgess, Revell et al. 2008). That is, 
melatonin is used to produce phase shifts in the biological clock. These 
shifts, like those produce with chronotherapy, are used to re-align one’s 
biologically based and preferred sleep phase with standard clock time. 
Bright Light Therapy uses an environmental cue to phase advance or 
phase delay circadian rhythms. Bright light therapy (BLT) has been shown 
to be effective in reducing sleep and circadian rhythm disturbances 
associated with a variety of disorders (e.g. jet lag, seasonal affective 
disorder, depression, delayed or advanced sleep phase and other sleep 

 
Page 8 of 36 
Revised: November 15, 2016 
disorders). Preliminary testing of BLT has been conducted in a variety of 
cancer patients to improve cancer-related fatigue, but not in patients with 
lung cancer. Additionally, the efficacy of BLT on improving sleep 
continuity disturbances, daytime functioning and quality of life has not 
been conducted with lung cancer survivors. Of the previously mentioned 
therapies, the proposed BLT delivered via eye mask may increase 
compliance, since the mask can be aimed directly at the eyes and 
treatment requires minimal effort. Light masks may be a more energy-
efficient (through the use of only eight LEDs) and portable method, 
compared to traditional light boxes. 
2.4 Include complete specific citations/references.  
 
Ancoli-Israel, S., P. J. Moore and V. Jones (2001). "The relationship 
between fatigue and sleep in cancer patients: a review." Eur J Cancer 
Care (Engl) 10(4): 245-255.  
Ancoli-Israel, S., M. Rissling, A. Neikrug, V. Trofimenko, L. Natarajan, B. 
A. Parker, S. Lawton, P. Desan and L. Liu (2012). "Light treatment 
prevents fatigue in women undergoing chemotherapy for breast cancer." 
Support Care Cancer 20(6): 1211-1219.  
Armaiz-Pena, G. N., S. W. Cole, S. K. Lutgendorf and A. K. Sood (2013). 
"Neuroendocrine influences on cancer progression." Brain Behav Immun 
30 Suppl: S19-25.  
Berger, A. M. and L. Farr (1999). "The influence of daytime inactivity and 
nighttime restlessness on cancerrelated fatigue." Oncol Nurs Forum 
26(10): 1663-1671.  
Berger, A. M., L. A. Farr, B. R. Kuhn, P. Fischer and S. Agrawal (2007). 
"Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior 
to adjuvant breast cancer chemotherapy." J Pain Symptom Manage 
33(4):398-409.  
Berger, A. M., M. Hertzog, C. R. Geary, P. Fischer and L. Farr (2012). 
"Circadian rhythms, symptoms, physical functioning, and body mass index 
in breast cancer survivors." J Cancer Surviv 6(3): 305-314.  
Berger, A. M., K. P. Parker, S. Young-McCaughan, G. A. Mallory, A. M. 
Barsevick, S. L. Beck, J. S. Carpenter, P. A. Carter, L. A. Farr, P. S. 
Hinds, K. A. Lee, C. Miaskowski, V. Mock, J. K. Payne and M. Hall 
(2005). "Sleep wake disturbances in people with cancer and their 
caregivers: state of the science." Oncol Nurs Forum 32(6): E98-126. 
Berger AM, Kuhn BR, Farr L, et al. (2009). One-year outcomes of a behavioral  
therapy intervention trial on sleep quality and cancer-related fatigue. J Clin Oncol,  
27: 6033-6040. 
 

 
Page 9 of 36 
Revised: November 15, 2016 
Borbely, A. A. (1982). "A two process model of sleep regulation." Hum 
Neurobiol 1(3): 195-204.  
Bower, J. E. (2006). "Management of cancer-related fatigue." Clin Adv 
Hematol Oncol 4(11): 828-829. Bower, J. E. (2007). "Cancer-related 
fatigue: links with inflammation in cancer patients and survivors." Brain 
Behav Immun 21(7): 863-871.  
Bower, J. E., P. A. Ganz, N. Aziz, R. Olmstead, M. R. Irwin and S. W. Cole 
(2007). "Inflammatory responses to psychological stress in fatigued breast 
cancer survivors: relationship to glucocorticoids." Brain Behav Immun 
21(3): 251-258.  
Bower, J. E., P. A. Ganz, K. A. Desmond, C. Bernaards, J. H. Rowland, B. 
E. Meyerowitz and T. R. Belin (2006).  
"Fatigue in long-term breast carcinoma survivors: a longitudinal 
investigation." Cancer 106(4): 751-758. Bower, J. E., P. A. Ganz, S. S. 
Dickerson, L. Petersen, N. Aziz and J. L. Fahey (2005). "Diurnal cortisol 
rhythm and fatigue in breast cancer survivors." 
Psychoneuroendocrinology 30(1): 92-100.  
Burgess, H. J. and L. F. Fogg (2008). "Individual differences in the 
amount and timing of salivary melatonin secretion." PLoS One 3(8): 
e3055.  
Burgess, H. J., V. L. Revell and C. I. Eastman (2008). "A three pulse phase 
response curve to three milligrams of melatonin in humans." J Physiol 
586(2): 639-647.  
Burgess, H. J., N. Savic, T. Sletten, G. Roach, S. S. Gilbert and D. Dawson 
(2003). "The relationship between the dim light melatonin onset and sleep 
on a regular schedule in young healthy adults." Behav Sleep Med 1(2): 
102114.  
Cella, D. (1998). "Factors influencing quality of life in cancer patients: 
anemia and fatigue." Semin Oncol 25(3 Suppl 7): 43-46.  
Cella, D., J. S. Lai and A. Stone (2011). "Self-reported fatigue: one 
dimension or more? Lessons from the Functional Assessment of Chronic 
Illness Therapy--Fatigue (FACIT-F) questionnaire." Support Care Cancer 
19(9): 1441-1450.  
Cleveland, W. S. (1994). Visualizing Data. Summit, NJ, Hobart Press.  
Corbett, M. A. (2013). "A potential aid to circadian adaptation: re-timer." 
Aviat Space Environ Med 84(10): 11131114.  
Davidson JR, MacLean AW, Brundage MD, Schulze K. (2002). Sleep  
disturbances in cancer patients. Soc Sci Med, 54(9):1309-21. 
 

 
Page 10 of 36 
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Davis, S., D. K. Mirick and R. G. Stevens (2001). "Night shift work, light 
at night, and risk of breast cancer." J Natl Cancer Inst 93(20): 1557-1562.  
Dean, G. E., D. S. Finnell, M. Scribner, Y. J. Wang, L. M. Steinbrenner 
and N. S. Gooneratne (2010). "Sleep in Lung Cancer: The Role of Anxiety, 
Alcohol and Tobacco." Journal of Addictions Nursing 21: 130-138. 2  
Dogliotti, L., A. Berruti, T. Buniva, M. Torta, A. Bottini, M. Tampellini, M. 
Terzolo, R. Faggiuolo and A. Angeli (1990). "Melatonin and human 
cancer." J Steroid Biochem Mol Biol 37(6): 983-987.  
Dolberg, O. T., S. Hirschmann and L. Grunhaus (1998). "Melatonin for 
the treatment of sleep disturbances in major depressive disorder." Am J 
Psychiatry 155(8): 1119-1121.  
Eckerberg, B., A. Lowden, R. Nagai and T. Akerstedt (2012). "Melatonin 
treatment effects on adolescent students' sleep timing and sleepiness in a 
placebo-controlled crossover study." Chronobiol Int 29(9): 1239-1248. 
Golombek, D. A., L. P. Casiraghi, P. V. Agostino, N. Paladino, J. M. 
Duhart, S. A. Plano and J. J. Chiesa (2013). "The times they're a-
changing: effects of circadian desynchronization on physiology and 
disease." J Physiol Paris 107(4): 310-322.  
Goedendorp MM, Gielissen MF, Verhagen CA, Bleijenberg G. (2013).  
Development of fatigue in cancer survivorship: a prospective follow-up study  
from diagnosis into the year after treatment. J Pain Symptom Manage, 45(2):213- 
22. 
 
Gooneratne, N. S., G. E. Dean, A. E. Rogers, J. E. Nkwuo, J. C. Coyne and 
L. R. Kaiser (2007). "Sleep and quality of life in long-term lung cancer 
survivors." Lung Cancer 58(3): 403-410.  
Hoffman, A. J., B. A. Given, A. von Eye, A. G. Gift and C. W. Given 
(2007). "Relationships among pain, fatigue, insomnia, and gender in 
persons with lung cancer." Oncol Nurs Forum 34(4): 785-792.  
Horne, J. A. and O. Ostberg (1976). "A self-assessment questionnaire to 
determine morningness-eveningness in human circadian rhythms." Int J 
Chronobiol 4(2): 97-110.  
Johns, M. W. (1991). "A new method for measuring daytime sleepiness: 
the Epworth sleepiness scale." Sleep 14(6): 540-545.  
Kapo, Jennifer M. MD,  Akgun, Kathleen M. MD, MS. (2015). Integrating  
palliative care into the care of patients with advanced lung cancer. Cancer Journal,  
21(5):434-439. 
 
Levin, R. D., M. A. Daehler, J. F. Grutsch, J. Quiton, C. G. Lis, C. 
Peterson, D. Gupta, K. Watson, D. Layer, S. HuffAdams, B. Desai, P. 
Sharma, M. Wallam, M. Delioukina, P. Ball, M. Bryant, M. Ashford, D. 

 
Page 11 of 36 
Revised: November 15, 2016 
Copeland, M. Ohmori, P. A. Wood and W. J. Hrushesky (2005). 
"Circadian function in patients with advanced non-small-cell lung 
cancer." Br J Cancer 93(11): 1202-1208.  
Liu, L., M. R. Marler, B. A. Parker, V. Jones, S. Johnson, M. Cohen-Zion, 
L. Fiorentino, G. R. Sadler and S. AncoliIsrael (2005). "The relationship 
between fatigue and light exposure during chemotherapy." Support Care 
Cancer.  
McCullagh, P. and J. A. Nelder (1989). Generalized linear models. 
London, UK, Chapman & Hall.  
Nishiura, M., A. Tamura, H. Nagai and E. Matsushima (2014). 
"Assessment of sleep disturbance in lung cancer patients: Relationship 
between sleep disturbance and pain, fatigue, quality of life, and 
psychological distress." Palliat Support Care: 1-7.  
Pachman DR, Barton DL, Swetz KM, Loprinzi CL. (2012). Troublesome  
symptoms in cancer survivors: fatigue, insomnia, neuropathy, and pain. J Clin  
Oncol. 20;30(30):3687-96. 
Palesh OG, Roscoe J, Mustian KM, et al. (2010). Prevalence, demographics, and  
psychological associations of sleep disruption in patients with cancer: University  
of Rochester Cancer Center-Community Clinical Oncology Program. J Clin  
Oncol, 28: 292-298. 
 
Redd, W. H., H. Valdimarsdottir, L. M. Wu, G. Winkel, E. E. Byrne, M. A. 
Beltre, E. S. Liebman, T. Erazo, J. A. Hayes, L. Isola, E. Scigliano, Y. 
Meschian, S. Lutgendorf and S. Ancoli-Israel (2014). "Systematic light 
exposure in the treatment of cancer-related fatigue: a preliminary study." 
Psychooncology.  
Roscoe J, Kaufman ME, Matteson-Rusby SE, et al. (2007). Cancer-related fatigue  
and sleep disorders. Oncologist, 12: 35-42.  
 
3.0 
Inclusion and Exclusion Criteria 
3.1 Describe the criteria that define who will be included or excluded in 
your final study sample.  
Fifty-two lung cancer survivors with sleep continuity disturbance will be 
recruited over 2 years. Eligibility criteria include the following: age >21, 
stage I-III, non-small cell lung cancer, >6weeks and <3years post-surgical 
resection who are medically and psychiatrically stable. Subjects must be 
able to give consent.  An NCI-designated comprehensive cancer center 
with a well-established thoracic surgery practice will be the recruitment 
site. A collaborative recruitment arrangement in the past has resulted in 
successful recruitment goal achievement.  
3.2 Describe how individuals will be screened for eligibility. 

 
Page 12 of 36 
Revised: November 15, 2016 
The PI or research assistant (RA) will screen all eligible participants for 
sleep apnea using the ApneaLink device. Participants who screen positive 
for sleep apnea will receive 2 printed reports of the ApneaLink results: one 
for themselves and a copy for their provider, who will be advised to refer 
the participant for further sleep evaluation. Following a negative screen 
for sleep apnea, participants will be evaluated for sleep continuity 
disturbance through the use of Insomnia Severity Index, Epworth 
Sleepiness Scale and 14-day sleep diaries. Participants will also be 
screened for circadian activity rhythm disturbance with 14-day actigraphy 
and Morningness-Eveningness Questionnaire. A folder will be provided 
with each of the pretreatment instruments to complete and an actigraph to 
wear 24/7 at home. Following completion of pretreatment measures, 
participants will be randomized using a random number assignment to 
either red-yellow (control dim light) versus blue-green (experimental 
bright light) directed light therapy. Participants will be trained on how to 
wear the directed light therapy for 60-minutes within 30-minutes upon 
awakening for 1-week (Redd et al., 2014).  
3.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of 
these populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
These populations will not be included in the study.  
3.4 Indicate whether you will include non-English speaking individuals.  
Provide justification if you will exclude non-English speaking 
individuals.  
(In order to meet one of the primary ethical principles of equitable 
selection of subjects, non-English speaking individuals may not be 
routinely excluded from research.  In cases where the research is of 
therapeutic intent or is designed to investigate areas that would 
necessarily require certain populations who may not speak English, 
the researcher is required to make efforts to recruit and include non-
English speaking individuals.  However, there are studies in which it 
would be reasonable to limit subjects to those who speak English: 
e.g., pilot studies, small unfunded studies with validated instruments 
not available in other languages, numerous questionnaires, and 
some non-therapeutic studies which offer no direct benefit.)  
Non-English speakers will not be included in the study because this is a 
pilot study. 
 

 
Page 13 of 36 
Revised: November 15, 2016 
 
4.0 
Study-Wide Number of Subjects (Multisite/Multicenter Only) 
4.1 If this is a multicenter study, indicate the total number of subjects to 
be accrued across all sites. 
This is not a multicenter study. 
5.0 
Study-Wide Recruitment Methods (Multisite/Multicenter Only) 
If this is a multicenter study and subjects will be recruited by methods not under 
the control of the local site (e.g., call centers, national advertisements) describe 
those methods.  Local recruitment methods are described later in the protocol. 
5.1 Describe when, where, and how potential subjects will be recruited. 
Response: NA 
 
5.2 Describe the methods that will be used to identify potential subjects. 
Response: NA 
 
5.3 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Response: NA 
 
6.0 
Multi-Site Research (Multisite/Multicenter Only) 
6.1 If this is a multi-site study where you are the lead investigator, 
describe the processes to ensure communication among sites, such 
as: 
• 
All sites have the most current version of the protocol, consent 
document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site 
(including approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and 
approved (including approval by the site’s IRB of record) 
before the modification is implemented. 
• 
All engaged participating sites will safeguard data as required 
by local information security policies. 
• 
All local site investigators conduct the study appropriately. 

 
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• 
All non-compliance with the study protocol or applicable 
requirements will reported in accordance with local policy. 
Response: NA 
 
6.2 Describe the method for communicating to engaged participating 
sites: 
• 
Problems. 
• 
Interim results. 
• 
The closure of a study 
Response: NA 
 
7.0 
Study Timelines 
7.1 Describe the duration of an individual subject’s participation in the 
study. 
Subjects will be expected to participate for approximately 10 weeks during 
which ApneaLink screening, completion of pre-intervention data 
collection, 1 week for intervention, and completion of post-intervention 
data collection will occur. 
7.2 Describe the duration anticipated to enroll all study subjects. 
Approximately 18 months. 
7.3 Describe the estimated date for the investigators to complete this 
study (complete primary analyses) 
December, 2017. 
8.0 
Study Endpoints 
8.1 Describe the primary and secondary study endpoints. 
The primary endpoint is whether subjects have a significant improvement 
in self-reported fatigue, sleep and circadian rhythms with the bright light 
intervention as compared to the dim light intervention.  The secondary 
endpoint is to determine whether pre-treatment subjects with circadian 
dysrhythmia (circadian phase and amplitude abnormalities) will be 
significantly more likely to exhibit treatment responses than those who 
were not identified as having circadian dysrhythmia.   
8.2 Describe any primary or secondary safety endpoints. 
Response: It is expected that some patients with stage I-III NSCLC may 
experience periods of low oxygenation during sleep that may be identified 
during screening with the ApneaLink. We added a letter of referral to give 
to patients who may wish to alert their Providers about this finding. 

 
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9.0 
Procedures Involved 
9.1 Describe and explain the study design. 
 
This pilot study will include 52 lung cancer survivors using a 2X2 mixed 
model with Pre-Post assessments in two groups. Twenty-six participants 
will be randomized to red yellow directed light (control) and 26 
participants will receive blue green (experimental) directed light therapy. 
The light source (Re-Timer) will be worn for 60-minutes every morning 
within 30-minutes upon awakening for 1-week. Participants will receive a 
weekly telephone call to ensure adherence to treatment plan and screen for 
safety/adverse events.  
9.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks.   
Screening for inclusion criteria includes a YES response to the following 
questions:  
Are at least 21 years of age? 
Do you have a diagnosis of non-small cell lung cancer stage I, II or III?  
Have you had your lung cancer surgically removed at least 6 weeks ago, 
but not longer than 3 years ago? 
Screening for exclusion criteria includes a NO response to the following 
questions: 
Do you have any unmanaged medical or psychiatric diagnoses? 
Are you currently pregnant? 
Do you have a diagnosis of epilepsy? 
Following informed consent, in order to rule-out sleep apnea as a 
confounder and assess for respiratory disturbance, all eligible participants 
will be screened for sleep apnea and hypoxia using the portable 
ApneaLink device for one night. Following a negative screen for sleep 
apnea, demographics, diagnoses, treatments, comorbidities, etc. will be 
recorded using the Demographics and Treatment Survey. Fatigue will be 
measured using the Functional Assessment of Chronic Illness Therapy 
Fatigue (FACIT) (Cella, Lai et al. 2011). Sleep continuity disturbance will 
be determined by Insomnia Severity Index (Bastien et al., 2001), 14-day 
sleep diary and the Epworth Sleepiness Scale (Johns 1991). Circadian 
activity rhythm disturbance will be assessed using the 14-day actigraph 
(Ambulatory Monitoring, Inc, Ardsley, NY) and Morningness-
Eveningness Horne-Ostberg/Questionnaire (MEQ) (Horne and Ostberg 
1976). Surveys and actigrahy will be performed at baseline and again after 
treatment ends. Expectation for treatment effectiveness will be assessed 
with the investigator developed Expectation Questionnaire before and 

 
Page 16 of 36 
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after treatment. Treatment adherence and safety will be evaluated by self-
report start/end time on sleep diaries and with weekly telephone/text 
reminders.  
9.3 Describe procedures performed to lessen the probability or 
magnitude of risks. 
Weekly telephone calls will be negotiated and utilized to identify Adverse 
Events and adherence, in addition to self-report adherence on sleep diaries. 
9.4 Describe all drugs and devices used in the research and the purpose 
of their use, and their regulatory approval status. 
Response:  
• Direct Light Therapy - Re-Timer is a directed light device, worn 
like a pair of glasses that produces a 100% UV-free red-yellow 
(dim light-control) or blue-green (bright light-experimental), which 
may improve sleep and reset circadian rhythms. Regulatory status: 
classified as a wellness device (no FDA classification as medical 
device) 
• ApneaLink – ApneaLink is a compact, lightweight, portable 
device used for overnight screening for sleep apnea, providing 
information about respiratory effort, pulse, oxygen saturation, 
nasal flow and snoring. Regulatory status: approved (FDA) 
• Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY) – is a 
wrist worn device that uses a piezoelectric sensor that generates a 
signal based on movement. The analog signal is then digitalized 
and for each 1-minute epoch an activity count is calculated and 
stored. Software application allow for objective sleep-wake 
patterns (total sleep time, sleep latency, wake after sleep onset, 
number of awakenings, sleep efficiency) and circadian activity 
rhythm assessment (mesor, amplitude, acrophase, etc.). Regulatory 
status: approved (FDA) 
9.5 Describe the source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection forms.) 
• Demographics and Treatment Survey: A general demographics 
questionnaire used to assess personal (age, gender), lifestyle (smoking 
history and current use of tobacco, stimulants, and alcohol), disease (stage 
and type of lung cancer) and treatment (schedule, type and dose of 
chemotherapy, other medications used and side effects) factors. 
• Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) 
(Cella, Lai et  al. 2011) – The FACIT Measurement System is a part of a 
collection of quality of life questionnaires targeted to the management of 
chronic illness. FACIT has 13-items with a 5-point Likert scale with well 
established validity and reliability to assess fatigue. 

 
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• Insomnia Severity Index (ISI) (Bastien et al., 2001) – is a self-report 
psychometrically sound instrument used to measure perceived insomnia 
severity.  
• Sleep diary – is a self-report instrument to prospectively assess an 
individual’s sleep. 
• Functional Assessment of Cancer Therapy-Lung Scale (Butt, Z., et 
al.,2005) FACT-L is a widely used quality of life instrument in lung 
cancer clinical trials and provides validated clinically meaningful score 
changes.  
• Epworth Sleepiness Scale (Johns 1991) – is a self-reported questionnaire 
assessing trait daytime sleepiness that relies on retrospective reports of 
dozing behavior in various hypothetical situations to establish an 
assessment of a patient’s global level of sleepiness.   
• Morningness-Eveningness Horne-Ostberg/Questionnaire (MEQ) 
(Horne and Ostberg 1976) – is a self-reported questionnaire used to 
determine individual differences in morningness and eveningness-the 
degree to which respondents are active and alert at certain times of the 
day. Results of this questionnaire inform circadian typology. 
• Treatment Expectation (investigator developed) self-report survey to 
determine treatment expectations for treatment effectiveness before 
and after treatment.  
• Pittsburgh Sleep Quality Index (Buysee et al., 1991), a 19-item, self-
report questionnaire assesses sleep quality and quantity. The PSQI 
assesses a range of sleep disturbances including: insomnia, sleep apnea 
and limb movement disorders, as well as daytime consequences of sleep. 
• Snellen Visual Acuity chart – Assess visual acuity before and after the 
interventions.  
• Brief Fatigue Inventory (Mendoza, 1999) – BFI is a valid and reliable measure 
of clinically significant fatigue, assessing fatigue severity, and impact of fatigue 
on daily functioning.  
• Hospital Depression and Anxiety Scale (Zigmond & Snaith, 1983). 
HADS is valid and reliable self-assessment of depression and anxiety for 
inpatients and outpatients. 
9.6 What data will be collected including long-term follow-up. 
Response: Quantitative data on demographics, disease and treatment; 
screening for sleep apnea; self-report data on sleep, fatigue and quality of 
life; movement data used for objective sleep-wake data; treatment adherence 
and treatment expectations.  
9.7 For HUD uses provide a description of the device, a summary of 
how you propose to use the device, including a description of any 

 
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Revised: November 15, 2016 
screening procedures, the HUD procedure, and any patient follow-
up visits, tests or procedures. 
N/A   
 
 
10.0 Data and Specimen Banking 
10.1 If data or specimens will be banked for future use, describe where 
the data/specimens will be stored, how long they will be stored, how 
the data/specimens will be accessed, and who will have access to the 
data/specimens. 
N/A 
 
10.2 List the data to be stored or associated with each specimen. 
N/A 
 
10.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
Response: N/A 
 
11.0 Data Management 
11.1 Describe the data analysis plan, including any statistical 
procedures. 
    
Hypothesis testing will be conducted using 2x2 ANOVAs for the first 
specific aim, with Logistic Regressions for the second specific aim 
(predicting treatment response and non-response) and with Linear and 
Logistic Regressions for the third specific aim (predicting illness severity 
and treatment response). 
11.2 Provide a power analysis. 
Response:  
The primary outcome for sleep is the sleep efficiency score. Previous 
research has indicated that persons with satisfactory sleep have a sleep 
efficiency score exceeding 85, whereas persons reporting unsatisfactory 
sleep have a score at most 70, with both groups reporting a standard 
deviation of approximately 15.  The estimated effect size from this study 

 
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is 1. The goal of this study is to improve sleep efficiency from an 
unsatisfactory level to a satisfactory level. Using a large effect size of .08 
with a one-tailed significance of .025 and power of 80%, the required 
sample size for the two-group comparison is 26 per group for a total 
sample of 52. 
 
 
11.3 Describe the steps that will be taken secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers 
and data) during storage, use, and transmission. 
All members of the research team have completed CITI training on ways 
to protect subject’s data throughout the research process. Following 
informed consent, each participant will be assigned a unique numeric 
identifier. Consents will be stored in a locked file cabinet in a locked 
office in the School of Nursing. Data will be de-identified before being 
coded, entered, stored securely, backed up regularly, and analyzed using 
the SPSS software at the University at Buffalo School of Nursing in room 
301B Wende Hall, 3435 Main Street, Buffalo, NY 14214. To ensure 
safety in data management and data analysis, data entry will be performed 
on a protected computer, secured by the University at Buffalo Standards 
for Securing Regulated Private Data and the New York State Information 
Security Breach Notification Act with access limited by UBIT safety 
policies to data management, including: secure server and computer, base 
encryption, UBIT password and name account verification and daily 
electronic secure back up. Data destruction will be manually performed in 
accordance with the applicable institutional schedule at the end of its life 
cycle.  
11.4 Describe any procedures that will be used for quality control of 
collected data. 
All data is initially checked by the PI for completeness and incomplete 
data is reviewed with participant to ensure incomplete answers were 
addressed. All data that is coded and entered will be independently 
verified by at least one other research team member, with monthly random 
checks performed by the PI. Data analysis will begin with an assessment 
of means, standard deviations, frequencies and confidence intervals to 
identify any outliers. Outlier data will be reviewed with statistician on data 
management. 
11.5 Describe how data and specimens will be handled study-wide: 
Response: Data will be de-identified by assigning a unique subject number 
to each consented participant's data file. De-identified data will be 
abstracted from the electronic medical record and recorded on the 
Demographics and Treatment Survey after each eligible participant is 

 
Page 20 of 36 
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consented. De-identified data will be tranferred to an SPSS file and stored 
on a password protected computer in a locked office in Wende Hall at the 
University at Buffalo School of Nursing within 24 hours. Demographics 
and Treatment Survey data will be stored in a locked file cabinet in room 
301B Wende Hall. The PI, Research Assistant and co-investigators will 
have will have access to the SPSS de-identified data files. 
11.6 What information will be included in that data or associated with the 
specimens? 
Response: Demographics, lifestyle data, lung cancer treatment history, 
current medications, sleep, fatigue and quality of life survey results, sleep 
apnea and oxygen saturation data and circadian activity rhythm data. 
11.7 Where and how data or specimens will be stored? 
Response: Data will be stored securely and backed up regularly at the 
University at Buffalo School of Nursing in room 301B Wende Hall, 3435 
Main Street, Buffalo, NY 14214. To ensure data safety, data entry will be 
performed on a protected computer, secured by the University at Buffalo 
Standards for Securing Regulated Private Data and the New York State 
Information Security Breach Notification Act with access limited by UBIT 
safety policies to data management, including: secure server and 
computer, base encryption, UBIT password and name account verification 
and daily electronic secure back up. 
11.8 How long the data or specimens will be stored? 
Data will be stored for a minimum of three years and data destruction will 
be manually performed in accordance with the applicable institutional 
schedule at the end of its life cycle. Each team member will access the 
data following the University at Buffalo Standards for Securing Regulated 
Private Data as mentioned above.  
11.9 Who will have access to the data or specimens? 
Members of the research team who have completed the required SUNY 
Buffalo CITI training will have access to data with UB secure access 
generated by UBIT password via authorized UB computers at University 
at Buffalo School of Nursing.  
11.10 Who is responsible for receipt or transmission of the data or 
specimens? 
The principal investigator and research assistant will be responsible for 
receipt of the data from participants. Once data is de-identified, data 
coders will code, enter, verify and analyze the data under the direction of 
the PI. This study will not use specimens.  
11.11How data and specimens will be transported? 
Response: De-identified survey data will be transported by the PI  in a 
briefcase.  

 
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12.0 Provisions to Monitor the Data and Ensure the Safety of Subjects 
12.1 Describe the plan to periodically evaluate the data collected 
regarding both harms and benefits to determine whether subjects 
remain safe.   
The PI will be responsible for ensuring data integrity and safety monitoring 
for human subjects and communicating any negative outcomes or any 
serious events to the IRBs and other offices/agencies. Because of the 
minimal to low risk associated with this protocol, the data safety and 
monitoring plan (DSMP) for this project involves close monitoring by the 
principal investigator (PI) and a safety officer, an Nurse Practitioner in the 
School of Nursing. The data safety monitoring team will ensure participant 
safety, ensure the validity and integrity of the data, monitor study progress, 
and make recommendations regarding appropriate protocol and operational 
changes which may have substantial effects upon the ultimate interpretation 
of the study. They will also be responsible for promptly report any serious 
adverse events to the Institutional Review Boards (IRB) at Roswell Park 
Cancer Institute, the VA Western New York Health Systems (VA 
WNYHS) and the University at Buffalo 
Weekly reviews of participant accrual will be conducted by the PI during 
weekly research meetings. If participant accrual and/or retention drop 
below what is required for successful completion of this study, the PI will 
alert the statistician and strategies will be developed to overcome the 
identified problems. Records from subjects recruited during that week will 
also be scrutinized to insure that all participants are eligible for 
participation in the study. The PI and members of the research team will be 
monitoring developments in the literature and results of related studies that 
may have an impact on the safety of participants or on the ethics for the 
research study. Additionally, Michael Perlis, PhD, a sleep research expert 
and consultant, will serve as a resource for new findings in the field and to 
assist with this clinical trial. 
12.2 Describe what data are reviewed, including safety data, untoward 
events, and efficacy data. 
Data review includes eligibility, referral for sleep apnea, referral for low 
oxygen during sleep, completion of data collection instruments, 
adherence to intervention, number of follow up phone calls accepted, and 
outcome measures of efficacy: fatigue, sleep and circadian activity 
rhythms. Daytime sleepiness will also be evaluated daily, but monitored 
weekly. 
12.3 Describe how the safety information will be collected (e.g., with case 
report forms, at study visits, by telephone calls with participants). 
Daytime sleepiness may be hazardous for patients at risk for falling asleep 
while driving, for example. This is a safety question that is monitored 

 
Page 22 of 36 
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daily and assessed weekly by telephone with the participant. It is also 
assessed at baseline and end of study with the Epworth Sleepiness Scale.  
12.4 Describe the frequency of data collection, including when safety 
data collection starts. 
Data collection will occur during and immediately following the screening 
process, and will continue throughout the intervention period (1-week), 
concluding with the post intervention data collection period (2-weeks). 
Data collection will be conducted approximately weekly, to include a 
safety question. The daytime sleepiness question is important to determine 
if participants are at risk for harm. 
12.5 Describe who will review the data. 
The PI will review the data for completeness, accuracy and safety. A 
second team member will code, enter, and then verify the data with a third 
member of the research team.  
12.6 Describe the frequency or periodicity of review of cumulative data. 
Cumulative data will be reviewed monthly by the PI. Data coding and 
entry errors will be identified and corrected. 
12.7 Describe the statistical tests for analyzing the safety data to 
determine whether harm is occurring. 
If a participant scores >10 on the Epworth Sleepiness Scale or scores a 3 
or higher on the daily sleepiness scale, we will discuss this result with the 
participant to determine if they are at risk for harm and monitor the patient 
more frequently. 
12.8 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: We do not anticipate any condition that would trigger an 
immediate suspension of the research. 
13.0 Withdrawal of Subjects 
13.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Subjects will be withdrawn from the research without their consent if they 
are unable to complete their responsibilities listed on the consent form or 
if they falsify responses. 
13.2 Describe any procedures for orderly termination. 
The participants that require early termination from the study will receive 
a telephone call alerting them to the termination and thanking them for 
their participation. If participants are not available via telephone, a letter 
notifying them of their termination will be mailed to their home address.  

 
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13.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
Response: It is conceivable that some participants may decide not to fully 
participate, for example, not wear the light therapy (i.e. Re-Timers), but 
complete survey and actigraph data. Their data is still valuable. Data 
collection would continue and participants would receive appropriate 
compensation. 
14.0 Risks to Subjects 
14.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to the subjects’ participation 
in the research. Include as may be useful for the IRB’s 
consideration, a description of the probability, magnitude, duration, 
and reversibility of the risks. Consider physical, psychological, 
social, legal, and economic risks. 
The known risks associated with this study include the possibility that 
participants may become upset thinking about some of the questions or topics in 
this study. If this occurs, the participant should notify the research assistant and 
will then be provided with an appropriate referral for assistance. The skin on the 
participant’s wrist may become irritated by wearing the actigraph. If this occurs, 
the participant will be advised to remove the actigraph, apply a thin layer of 
Eurcerin lotion to the affected area and wear the actigraph on the opposite wrist.  
14.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
Response: N/A 
 
14.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: N/A 
 
14.4 If applicable, describe risks to others who are not subjects. 
Response: N/A 
 
15.0 Potential Benefits to Subjects 
15.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
Response: Preliminary testing of the efficacy of light therapy has 
demonstrated an improvement in sleep continuity disturbances, daytime 

 
Page 24 of 36 
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functioning and quality of life in a variety of cancer survivors. Participants 
may benefit with a better sleep quality and overall quality of life. 
Furthermore, this light therapy device (i.e. Re-Timer) may be a more 
energy-efficient (through the use of LEDs) and convenient (portable 
method), compared to traditional light boxes. 
15.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. 
Response: Some participants may not achieve any benefit from this 
therapy. 
 
16.0 Vulnerable Populations 
16.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
• 
If the research involves pregnant women, review 
“CHECKLIST: Pregnant Women (HRP-412)” to ensure that 
you have provided sufficient information. 
• 
If the research involves neonates of uncertain viability or non-
viable neonates, review “CHECKLIST: Neonates (HRP-413)” 
or “HRP-414 – CHECKLIST: Neonates of Uncertain Viability 
(HRP-414)” to ensure that you have provided sufficient 
information. 
• 
If the research involves prisoners, review “CHECKLIST: 
Prisoners (HRP-415)” to ensure that you have provided 
sufficient information. 
• 
If the research involves persons who have not attained the 
legal age for consent to treatments or procedures involved in 
the research (“children”), review the “CHECKLIST: Children 
(HRP-416)” to ensure that you have provided sufficient 
information. 
• 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to 
ensure that you have provided sufficient information. 
• 
Consider if other specifically targeted populations such as 
students, employees of a specific firm or 
educationally/economically disadvantaged persons are 
vulnerable to coercion or undue influence.  The checklists 
listed above for other populations should be used as a guide to 
ensure that you have provided sufficient information.  
N/A 
 
17.0 Community-Based Participatory Research 

 
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17.1 Describe involvement of the community in the design and conduct of 
the research. 
Response: N/A 
 
Note: “Community-based Participatory Research” is a collaborative 
approach to research that equitably involves all partners in the 
research process and recognizes the unique strengths that each 
brings. Community-based Participatory Research begins with a 
research topic of importance to the community, has the aim of 
combining knowledge with action and achieving social change to 
improve health outcomes and eliminate health disparities. 
18.0 Sharing of Results with Subjects 
18.1 Describe whether or not results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic 
tests, or incidental findings) will be shared with subjects or others 
(e.g., the subject’s primary care physicians) and if so, describe how 
it will be shared. 
Response: Sleep apnea and nighttime oxygenation results will be reported 
to participants and, if abnormal, to the participant’s primary provider if we 
receive permission from the participant to do so. 
19.0 Setting 
19.1 Describe the sites or locations where your research team will 
conduct the research.  
Response: Roswell Park Cancer Institute, VA WNYHS and Cancer Care 
of Western New York will be the sites used to conduct the research. 
19.2 Identify where your research team will identify and recruit potential 
subjects. 
Response: The research team will identify and recruit potential subjects in 
the thoracic clinics at Roswell Park Cancer Institute, VA WNYHS and  
Western New York oncology offices and community centers that provide 
service to patients with lung cancer. 
19.3 Identify where research procedures will be performed. 
Response: Research procedures will be conducted in the thoracic clinics at 
Roswell Park Cancer Institute, VA WNYHS and Western New York 
oncology offices and community centers that provide service to patients 
with lung cancer. 
19.4 Describe the composition and involvement of any community 
advisory board. 
Response: N/A 

 
Page 26 of 36 
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19.5 For research conducted outside of the organization and its affiliates 
describe: 
• Site-specific regulations or customs affecting the research for 
research outside the organization. 
• Local scientific and ethical review structure outside the 
organization. 
Response: N/A 
 
20.0 Resources Available 
20.1 Describe the qualifications (e.g., training, experience, oversight) of 
you and your staff as required to perform their role. When 
applicable describe their knowledge of the local study sites, culture, 
and society. Provide enough information to convince the IRB that 
you have qualified staff for the proposed research. Note- If you 
specify a person by name, a change to that person will require prior 
approval by the IRB. If you specify people by role (e.g., coordinator, 
research assistant, co-investigator, or pharmacist), a change to that 
person will not usually require prior approval by the IRB, provided 
that person meets the qualifications described to fulfill their roles. 
Response: The PI completed a 2-year fellowship in Sleep and Respiratory 
Neurobiology at the University of Pennsylvania in 2006 and has 
conducted a variety of funded sleep studies at RPCI. The PI has 
collaborated with medical oncology for the past 5 years and thoracic 
surgery for the past year at RPCI and the VA WNYHS. The research team 
includes School of Nursing faculty who are sleep experts serving as co-
investigators (Dickerson and Jungquist), a graduate nursing student 
learning to become a sleep scientist (Carleara Ferreira da Rosa Silva), two 
consultants (Perlis and Wright) who are experts in insomnia treatment and 
light therapy to improve circadian rhythms and a collaborating thoracic 
surgeon (Dexter). The PI has been looking for a project to collaborate with 
Dr. Shah at Cancer Care of Western New York.  
Describe other resources available to conduct the research: For example, 
as appropriate: 
20.2 Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
Roswell Park Cancer Institute admits approximately 700 new patients with 
lung cancer annually. More than 400 of those 700 patients have stage I-III 
disease. Fifty lung cancer survivors with sleep continuity disturbance will 

 
Page 27 of 36 
Revised: November 15, 2016 
be recruited over 2 years. Not all lung cancer survivors have sleep 
continuity disturbance, but in our current sleep study, we were able to 
recruit 20 lung cancer survivors with insomnia within 6 months at Roswell 
Park Cancer Institute. Retention rate of study participants is anticipated to 
be 80% based on our previous experience. Oversampling will result in the 
desired target sample size at this rate. At the time of enrollment in the 
study, three forms of contact information will be obtained, email address, 
telephone number, and address for delivery of the data collection 
instruments and return mailers. In addition, an alternate contact person 
will be obtained to help decrease loss to follow up due to the length of the 
study. 
20.3 Describe the time that you will devote to conducting and completing 
the research. 
Response: 20% of the PI’s research time, 10% of the Co-I’s time and the 
RA will work 10 hours/week on this study. 
20.4 Describe your facilities. 
Response: Recruitment Site: Roswell Park Cancer Institute (RPCI) was 
founded in 1898 is America's first cancer center and holds the National 
Cancer Institute designation of "comprehensive cancer center." RPCI has 
133 hospital beds and 12 multidisciplinary clinics and is the only 
comprehensive cancer center of Western New York area. As a member of 
the prestigious National Comprehensive Cancer Network, RPCI has 
played a vital part in setting clinical guidelines for the care of Oncology 
patients. RPCI plays a pivotal part in cancer research with several ongoing 
funded research projects. 
The thoracic clinic provides state of the art comprehensive 
multidisciplinary care to approximately 700 patients with lung cancer 
annually. The presence of several specialties -pulmonary medicine, 
medical oncology and thoracic surgery along with the undiagnosed clinic 
in a single location with additional support from nearby radiation 
oncology clinics and interventional radiation ensures excellent patient care 
and satisfaction. The patients with lung masses and suspected lung cancer 
are promptly seen by the pulmonary clinic or the undiagnosed clinic and 
scheduled for diagnostic biopsy procedures. Several multidisciplinary 
meetings are conducted each week to make complicated management 
decisions for the patients. 
The VA WNYHS provides care to approximately 100 newly diagnosed 
veterans with lung cancer annually. 
 
Research Offices: The University at Buffalo School of Nursing (SON) is 
located in Wende Hall, a newly renovated historic building on the South 
Campus, is in close proximity to the four other Health Sciences Schools of 
Medicine, Dentistry, Pharmacy, and Public Health and Health Related 

 
Page 28 of 36 
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Professions. As a SON situated in a research intensive university, creation, 
translation, and transmission of knowledge is an expectation of faculty in 
support of the University mission. Excellence in teaching and service to 
the university, the community and the profession are also expectations in 
support of the mission and goals of the University and SON. A variety of 
offices, classrooms, and conference rooms are available for faculty. There 
are two videoconferencing rooms in the SON to accommodate a recently 
funded distance education PhD grant as well as other videoconferencing 
facilities located in the Health Sciences Library. The PI has 10 wrist-
actigraphs (Octogonal Sleep Watch 2.0) and ActionW software (Version 
2.0) purchased from Ambulatory Monitoring, Ardsley, NY, to use in this 
study. 
20.5 Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated consequences of the 
human research. 
Response: Roswell Park Cancer Institute, VA WNYHS and Western New 
York oncology offices and community centers that provide service to 
patients with lung cancer have dedicated social workers and a psychologist 
assigned to ambulatory clinics. 
20.6 Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions. 
Response: When we begin a new study, we take turns reading the research 
protocol out loud during a team meeting to ensure each member of the 
team has read the protocol and understands it. Team members are 
encouraged to ask questions about the research protocol during the 
meeting. We each perform the research procedures that we ask research 
participants to engage in to increase our understanding of the 
procedures/process and ensure the data collection instruments collect the 
information that we require. 
21.0 Prior Approvals 
21.1 Describe any approvals that will be obtained prior to commencing 
the research. (E.g., school, external site. funding agency, laboratory, 
radiation safety, or biosafety approval.) 
Response: This study is funded by the Oncology Nursing Society 
Foundation. Before releasing the funding, University @ Buffalo’s IRB 
approval is needed. 
22.0 Recruitment Methods 
22.1 Describe when, where, and how potential subjects will be recruited. 
The Principal Investigator will screen medical records for eligibility 
criteria. Potential participants will be approached face to face and after 

 
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Revised: November 15, 2016 
signed informed consent will be randomly assigned to control and 
experimental group. 
22.2 Describe the source of subjects. 
Response: All participants at Roswell Park Cancer Institute, VA WNYHS 
and Western New York oncology offices and community centers that 
provide service to patients with lung cancer meeting the eligibility criteria. 
 
22.3 Describe the methods that will be used to identify potential subjects. 
Potential participants will be screened for eligibility criteria by reviewing 
electronic medical records for eligibility in the thoracic clinics at Roswell 
Park Cancer Institute, VA WNYHS and Western New York oncology 
offices and community centers that provide service to patients with lung 
cancer.   
22.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Response: An IRB-approved recruitment flyer will be used.  
22.5 Describe the amount and timing of any payments to subjects. 
Response: A total of $50 will be paid to participants that complete data 
collection. After completing baseline data participants will receive $25 
and after completing f/u data collection participants will receive another 
$25. 
23.0 Local Number of Subjects 
23.1 Indicate the total number of subjects to be accrued locally. 
Response: 50 
 
23.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
Response: 50 recruited and 40 to complete. We anticipate approximately 
80% retention from previous research on this patient population.  
24.0 Confidentiality 
Describe the local procedures for maintenance of confidentiality. 

 
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24.1 Where and how data or specimens will be stored locally? 
De-identified data will be coded, entered, store securely, backed up 
regularly, and analyzed using the SPSS software at the University at 
Buffalo School of Nursing phone number 716-829-3235 at Room 301B 
Wende Hall, at 3435 Main Street, Buffalo, NY 14214. To ensure safety in 
data management and data analysis, data entry will be performed in a 
protected computer, secured by the University at Buffalo Standards for 
Securing Regulated Private Data and the New York State Information 
Security Breach Notification Act with access limited by UBIT safety 
policies to data management, including: locked server and computer, base 
encryption, UBIT password and name account verification, daily 
electronic secure back up and locked store.  
24.2 How long the data or specimens will be stored locally? 
Response: 3 years. 
 
24.3 Who will have access to the data or specimens locally? 
Response: Research team members. 
 
24.4 Who is responsible for receipt or transmission of the data or 
specimens locally? 
The principal investigator and research assistant will be responsible for 
receipt of the data.  
 
24.5 How data and specimens will be transported locally? 
Response: The PI will transport the surveys from Roswell Park Cancer 
Institute, VA WNYHS and Western New York oncology offices and 
community centers that provide service to patients with lung cancer to UB 
School of Nursing in a briefcase. 
25.0 Provisions to Protect the Privacy Interests of Subjects 
25.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
All reasonable efforts will be used to protect the confidentiality of the 
participants’ protected health information. Identifiable data is immediately 
de-identified and de-identified data is stored separately from identifiable 
data. The results of this research will be published. However, we will keep 
participants’ names and other identifying information confidential.   

 
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25.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
Response: To ensure participants feel at ease with the research situation in 
terms of the questions being asked and the procedures being performed, 
the PI or RA will conduct the informed consent process in a private room 
with the participant and family member(s) (participant’s discretion) in 
attendance. PI/RA will provide a schema of the procedures and examples 
of the surveys and equipment used in the study in an unhurried manner to 
allow the participant time to absorb and process the information and allow 
for questions and answers about their participation. 
25.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
Response: A HIPAA Partial Waiver has been requested to access the 
electronic medical record in order to determine participant eligibility. 
26.0 Compensation for Research-Related Injury 
26.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury. 
Response: N/A 
 
26.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
Response: N/A 
 
27.0 Economic Burden to Subjects 
27.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
Subjects will have no cost related to their participation in this research.  
28.0 Consent Process 
28.1 Indicate whether you will be obtaining consent 
Written informed consent will be obtained at the recruitment.  
28.2 Describe where  the consent process take place 
Consent process will take place in the thoracic clinics at Roswell Park 
Cancer Institute, VA WNYHS and Cancer Care of Western New York. 
28.3 Describe any waiting period available between informing the 
prospective subject and obtaining the consent. 

 
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Revised: November 15, 2016 
Response: Participants may sign consent within 30-minutes of learning 
about the study, but may take as long as they need before signing the 
consent. 
28.4 Describe any process to ensure ongoing consent. 
Response: At each contact with participants, the PI/RA will routinely 
remind them of their volunteer status and ability to withdraw from 
participation at any time. 
28.5 Describe whether you will be following “SOP: Informed Consent 
Process for Research (HRP-090).” If not, describe: 
• 
The role of the individuals listed in the application as being 
involved in the consent process. 
• 
The time that will be devoted to the consent discussion. 
• 
Steps that will be taken to minimize the possibility of coercion 
or undue influence. 
• 
Steps that will be taken to ensure the subjects’ understanding. 
Response: This study will follow SOP: Informed Consent Process for 
Research (HRP-090). 
Non-English Speaking Subjects  
28.6 Indicate what language(s) other than English are likely to be 
spoken/understood by your prospective study population or their 
legally authorized representatives. 
Non – English speaking participants will not be included in this study. 
28.7 If subjects who do not speak English will be enrolled, describe the 
process to ensure that the oral and written information provided to 
those subjects will be in that language. Indicate the language that 
will be used by those obtaining consent. 
Response: N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
28.8 Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations. Provide any additional 
information necessary here: 
Response: N/A 
28.9 If the research involves a waiver the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of 
Consent for Emergency Research (HRP-419)” to ensure you have 
provided sufficient information for the IRB to make these 
determinations. Provide any additional information necessary here: 

 
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Revised: November 15, 2016 
Response: N/A 
Subjects who are not yet adults (infants, children, teenagers) 
28.10Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent to 
treatments or procedures involved in the research under the 
applicable law of the jurisdiction in which the research will be 
conducted. (E.g., individuals under the age of 18 years.) For 
research conducted in NY state, review “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” to be aware 
of which individuals in the state meet the definition of “children.” 
Response: Age will be determined from the electronic medical record. 
28.11For research conducted outside of NY state, provide information that 
describes which persons have not attained the legal age for consent 
to treatments or procedures involved the research, under the 
applicable law of the jurisdiction in which research will be 
conducted. One method of obtaining this information is to have a 
legal counsel or authority review your protocol along the definition 
of “children” in “SOP: Legally Authorized Representatives, 
Children, and Guardians (HRP-013).” 
Response: N/A 
28.12Describe whether parental permission will be obtained from: 
• 
Both parents unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only one 
parent has legal responsibility for the care and custody of the 
child. 
• 
One parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the 
care and custody of the child. 
Response: N/A 
28.13Describe whether permission will be obtained from individuals other 
than parents, and if so, who will be allowed to provide permission. 
Describe the process used to determine these individuals’ authority 
to consent to each child’s general medical care. 
Response: N/A 
28.14Indicate whether assent will be obtained from all, some, or none of 
the children. If assent will be obtained from some children, indicate 
which children will be required to assent. 
Response: N/A 
28.15When assent of children is obtained describe whether and how it will 
be documented. 

 
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Revised: November 15, 2016 
Response: N/A 
Cognitively Impaired Adults 
28.16Describe the process to determine whether an individual is capable 
of consent. The IRB sometimes allows the person obtaining assent to 
document assent on the consent document and does not 
automatically require assent documents to be used. 
Response: Eligible participants will be monitored during the screening and 
consent process for indications that they understand.  
Adults Unable to Consent 
When a person is not capable of consent due to cognitive impairment, a 
legally authorized representative should be used to provide consent and, 
where possible, assent of the individual should also be solicited. 
28.17List the individuals from whom permission will be obtained in order 
of priority. (e.g., durable power of attorney for health care, court 
appointed guardian for health care decisions, spouse, and adult 
child.)  For research conducted in NY state, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“legally authorized representative.”  The list in the consent template 
signature section corresponds to the priority list for NYS.   
Response: N/A 
28.18For research conducted outside of NY state, provide information that 
describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in 
the procedure(s) involved in this research. One method of obtaining 
this information is to have a legal counsel or authority review your 
protocol along the definition of “legally authorized representative” 
in “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013).” 
Response: N/A 
28.19Describe the process for assent of the subjects. Indicate whether: 
• 
Assent will be required of all, some, or none of the subjects. If 
some, indicated, which subjects will be required to assent and 
which will not. 
• 
If assent will not be obtained from some or all subjects, an 
explanation of why not. 
• 
Describe whether assent of the subjects will be documented 
and the process to document assent. The IRB allows the person 
obtaining assent to document assent on the consent document 
and does not routinely require assent documents and does not 
routinely require subjects to sign assent documents. 

 
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Revised: November 15, 2016 
Response: Signed informed consent is required of all participants for this 
study. 
28.20For HUD uses provide a description of how the patient will be 
informed of the potential risks and benefits of the HUD and any 
procedures associated with its use. 
Response: N/A 
29.0 Process to Document Consent in Writing 
 
If your research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent. 
(If you will document consent in writing, attach a consent document. If you will 
obtain consent, but not document consent in writing, attach a consent script. 
Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” 
to ensure that you have provided sufficient information. You may use 
“TEMPLATE CONSENT DOCUMENT (HRP-502)”to create the consent 
document or script.) 
29.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be obtained including whether or not 
it will be documented in writing. 
Response: This study will require SOP: Written Documentation of 
Consent (HRP-091). 
30.0 Drugs or Devices 
30.1 If the research involves drugs or device, describe your plans to store, 
handle, and administer those drugs or devices so that they will be 
used only on subjects and be used only by authorized investigators. 
Response: The device used in this research study is already available 
commercially. 
If the drug is investigational (has an IND) or the device has an IDE or a 
claim of abbreviated IDE (non-significant risk device), include the 
following information: 
30.2 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response: N/A 
30.3 Explain procedures followed to comply with FDA sponsor 
requirements for the following: 

 
Page 36 of 36 
Revised: November 15, 2016 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: N/A