Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
Phase: NA
Conditions: Insomnia
Sponsor: Georgetown University

 
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Social and Behavioral Protocol Template 
 
To be used for Social and Behavioral studies only.  If this study is using investigational drugs and 
medical devices, special diets and/or radioactive materials please complete the Biomedical Protocol 
Template instead. 
 
Please answer every question, and mark N/A if not applicable.  Please submit this form plus copies of 
required documents such as consent forms, questionnaires, surveys, interview scripts, subject 
recruitment materials, and the responsible participant form.  If you have questions about this form, 
please contact the appropriate IRB office.  
 
I.  BASIC INFORMATION 
 
1. Title of Study 
Include the full protocol title 
Assessing the feasibility of web-based insomnia treatment among prostate cancer 
survivors      
2. Principal Investigator 
Name: Traci Bethea, PhD, MPA 
Institutional Affiliation:Georgetown 
Department:Oncology 
Phone Number:202-687-9372 
Email:tb988@georgetown.edu 
3. Location(s) of Research  
Describe the sites/locations* for the research and any site-specific regulations or customs affecting 
the research at those sites.  
*Sites: institution or place where the research is conducted. Location: specific state or country.  
In addition, describe any local scientific/ethical reviews completed for those sites and attach the 
ethics review in the SmartForm.  Information on international laws and regulations governing 
human research is available at: https://www.hhs.gov/ohrp/international/compilation-human-
research-standards/index.html 
Office of Minority Health and Health Disparities Research. 
4. Anticipated dates of research  
Includes contact with human subjects and analysis of identifiable data. Applications to the IRB 
must be submitted prior to any interactions with human subjects.  
Start Date: 8/15/2024 
End Date: 8/14/2025 
 
II. STUDY INFORMATION 
 
1. Version Number and Date 
Keep a version of this document in a Word format. Version control is important when protocols are 
being created or revised; it helps to track changes and identify when key decisions were made along 
the way. Version control allows the study team and regulatory groups to identify which version of a 
protocol was approved and applicable at a particular time. Versions can be documented by date 
and/or chronologic numbering each time you submit a modified protocol document. If you have to 
submit revisions to the protocol, revise this document and note a new version below. 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
Initial V1 
 
NA 
NA 
V2 
May 2, 
2025 
Update for compenstation when no technology-related 
data collection available 
Yes 
No 
V3 
      
      
Yes 
No 
V4 
      
      
Yes 
No 

 
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2. Study Specific Abbreviations and Definitions 
CBT-I – cognitive-behavioral therapy for insomnia 
DEXA – dual energy x-ray absorptiometry 
ISI – Insomnia Severity Index 
NCCN – National Comprehensive Cancer Network 
OMH – Office of Minority Health and Health Disparities Research 
PCS – prostate cancer survivor 
PRO – patient-reported outcome 
RCT – randomized controlled trial 
SHUTi – Sleep Healthy Using The Internet 
SIESTA-P Study – Assessing the feasibility of web-based insomnia treatment among 
prostate cancer survivors study 
3. Purpose of Study  
Provide a concise explanation of the research project you are undertaking, including: 
• 
Purpose, objectives, or hypothesis for the study 
• 
What you hope to learn from the research 
The purpose of this pilot study is to investigate a web-based cognitive behavioral therapy for 
insomnia (CBT-I) treatment among Black prostate cancer survivors and to collect preliminary data, 
including effect sizes, for a future appropriately sized study. Thus, the objectives of this study are 
to: 
1. Assess the feasibility of conducting a RCT using a web-based CBT-I intervention (Sleep Healthy 
Using the Internet, SHUTi) among Black prostate cancer survivors; 
2. Assess the acceptability of SHUTi among Black prostate cancer survivors; 
3. Assess the efficacy of SHUTi among Black prostate cancer survivors; and 
4. Assess the impact of SHUTi on non-insomnia patient-reported outcomes (PROs) among Black 
prostate cancer survivors. 
4. Background  
Provide the scientific or scholarly background for, rationale for, and significance of the research 
based on the existing literature and how it will add to existing knowledge.  
State how your research project is a logical step in studying the topic.  
Note: this section should be limited to only information directly related to the research questions 
and objectives. Do not include your full dissertation proposal. Include a synopsis of the most 
immediately relevant previous studies, if any, that have been conducted. Include relevant research 
references. 
There is a non-pharmacological internet-based self-administered treatment for insomnia 
called SHUTi (Sleep Healthy Using the Internet) that has been shown to be effective in 
multiple randomized trials among populations that were predominantly White. There were 
few Black participants and there is little evidence of the effectiveness of this treatment 
among Black men. The goal of this study is to assess the feasibility, acceptability, and 
efficacy of a web-based cognitive behavioral therapy for insomnia (CBT-I; SHUTi) among 
Black prostate cancer survivors, an understudied population with unique sleep challenges. 
Multiple clinical trials have demonstrated efficacy for SHUTi in a variety of populations. 
However, few studies have included appreciable numbers of Black participants or cancer 
survivors. In an RCT among middle-aged and older Black women, both the standard 
version and a culturally-tailored version of SHUTi were associated with clinically 
significant improvements in insomnia symptoms, although engagement was higher among 
participants who received the tailored intervention. 
Prostate cancer has the highest incidence rate and second highest mortality rate among men 
in the U.S. with a highest burden of both incidence and mortality among Black men 
compared to men of other racial/ethnic groups. Incidence rates in DC (131.3 per 100,000) 
and Maryland (132.7 per 100,000) exceed the national average (109.9 per 100,000). 
Insomnia is a risk factor for poor physical, cognitive, and psychosocial outcomes, including 

 
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depression, anxiety, frailty, and diminished cognitive function, especially among cancer 
survivors. Although cancer treatment, including androgen deprivation therapy, may 
increase insomnia symptoms and the prevalence of insomnia among prostate cancer 
survivors is estimated to be 25-39%, few studies have examined treatment of insomnia in 
this population and few have included collection of objective sleep data. Insomnia is 
associated with greater symptom burden (e.g., greater depression, greater distress, greater 
anxiety, greater fatigue, poorer cognition) among prostate cancer survivors, so treating 
insomnia may provide an opportunity to improve well-being in this population. 
CBT-I has demonstrated substantial and persistent improvements in insomnia severity 
among cancer survivors such that the National Comprehensive Cancer Network (NCCN) 
recommends CBT-I “as the preferred treatment for insomnia.” Trials to develop and test 
web-based and digital CBT-I interventions have shown non-inferiority to in-person 
administration by a trained therapist and increase availability of insomnia treatment to more 
patients. Recent NCCN guidelines note that improving sleep may provide additional 
benefits by resulting in less fatigue, better mood, better quality of life, and improved 
survival. CBT-I trials have also observed improvements in symptom burden regardless of 
delivery modality (i.e., in-person, via telephone, digitally/via the internet). SHUTi has 
demonstrated efficacy among breast cancer survivors and both the standard version of 
SHUTi and a culturally-tailored version of SHUTi demonstrated efficacy among middle-
aged and older Black women. However, to date, this accessible and interactive intervention 
has not been investigated among prostate cancer survivors. Thus, the Assessing the 
feasibility of web-based insomnia treatment among prostate cancer survivors study 
(SIESTA-P Study) will provide preliminary data to help address these gaps in the literature. 
Further, little is know about biomarkers of the health impact of CBT-I, so the SIESTA-P 
Study will collect both blood samples and digital biomarkers. 
5. Study Intervention(s) 
Describe the study intervention(s) if any. Indicate NA if there are no interventions. Note: 
Intervention includes both physical procedures by which information or biospecimens are gathered 
(e.g., venipuncture) and manipulations of the subject or the subject's environment that are 
performed for research purposes. 
The study intervention, SHUTi, is a web-based CBT-I treatment program that involves 
participation in six modules called Cores. Each participant randomized to the intervention 
arm will log in to the six modules of their assigned treatment program over a 6-9 week 
period. The program is designed to provide tailored instructions about how to improve a 
person’s sleep. The Cores are completed one at a time in order and each Core is expected to 
take 45-60 minutes to complete. Each Core contains information and exercises designed to 
help change behaviors and thoughts that can contribute to sleep problems. Participants will 
receive automated emails encouraging them to complete tasks. Participants will be asked to 
complete weekly to dos and enter daily sleep diaries to track their sleep. After each module, 
participants will need to complete 5 sleep diaries to proceed to the next module (~2 minutes 
to complete each). 
6. Procedures Involved 
a. Select the methods that will be employed in this study (select all that apply): 

 
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☐ Audio Recording 
☐ Video Recording 
☐ Psychophysiological Recording 
☐ Behavioral Observations 
☐ Educational Record Review* 
☐ Behavioral Interventions  
☐ Focus Groups 
☐ Record Review – Other 
☐ Interviews 
☒ Specimen Collection or Analysis 
☒ Surveys and/or Questionnaires 
☒ Mobile Applications 
☐ Psychometric Testing 
☐ Secondary Data Analysis 
☒ Other Social-Behavioral Procedures: Staff measurement (e.g., anthropometrics, blood 
pressure) 
*Records obtained from schools or other educational institutions 
b. Provide the following: 
 
a description of the activities that will be conducted throughout the course of the study, 
including any interaction, how intervention will be used, observation, or experiment 
involving human subjects, including control groups when applicable.  
 
a description of the strategy you will adopt to obtain and retain contact information as 
well as how you will re-contact subjects in the event any follow-up is planned. 
 
List any 3rd-party service providers used for data collection, transcription, analysis, etc. 
We will conduct a 2-arm pilot RCT among Black adults diagnosed with invasive prostate cancer 
with symptoms of insomnia based on the Insomnia Severity Index. The study will recruit 40 
participants and randomize them 1:1 to the SHUTi program (i.e., intervention) or web-based sleep 
hygiene materials (i.e., usual care) after study enrollment data collection. The service provider for 
the SHUTi program - including both the intervention and usual care conditions - is the University of 
Virginia's Center for Behavioral Health and Technology. Study enrollment data collection will 
include staff measurement of anthropometrics (i.e., height; weight; neck, waist, and hip 
circumferences; DEXA scan) and blood pressure and a blood draw; participants will complete study 
questionnaires and 10 sleep diaries. 
 
Study questionnaires will collect data on a variety of factors, including participants' demographics 
and socioeconomic status, cancer diagnosis and treatment, comorbidites and health behaviors, 
insomnia symptoms, sleep quality, sleep environment and habits, beliefs about sleep, comorbidities, 
quality of life, depressive symptoms, anxiety symptoms, and cognitive function. 
 
Participants with a compatible Bluetooth-enabled smartphone may be asked to complete an at-home 
sleep test via a wearable pulse oximeter (i.e., Wesper test kit) and downloaded smartphone 
application at enrollment and follow-up. Compatible smartphones include iPhone 7 and later 
modelsup, smartphones that run iOS versions 15 and later, and the latest Android versions (e.g., 12 
and later). Only a subset of participants will be consented to this data collection. The service 
provider for the at-home sleep test is Wesper, Inc. The at-home sleep test kits will be mailed to the 
servie provider with a prepaid shipping label after use. 
 
The service provider for the actigraphy data is Fitabase/Small Steps Labs LLC. Participants who are 
not interested in the at-home sleep test may be invited to complete 1 week of wrist actigraphy via a 
Fitbit Charge 5 at enrollment and follow-up. Only a subset of participants would be consented to 
this data collection and these participants will keep the Fitbit devices after use. 
 
The study presents minimal risk and requires re-contact, but does not require ongoing monitoring. 
The intervention is delivered via 6 modules that are released in the program over the course of 6-9 
weeks. The intervention program is fully automated with interactive and personalized components; 
personalization requires that participants input information from sleep diaries. Participants will 
complete follow-up data collection (i.e., anthropometric measurements, blood pressure, blood draw, 
study questionnaires, actigraphy) 10-12 weeks after randomization. Participants who complete the 
follow-up questionnaire will be asked for permission to re-contact them in the future. 

 
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Potentially eligible participants' contact information will be collected via medical record review and 
confirmed or updated during the eligibility screening. Contact information will be retained to 
facilitate scheduling the follow-up data collection. 
 
7. Study Materials (subject and non-subject facing materials) 
Describe and attach copies of any questionnaires, interviews, standardized tests, or any other data 
collection instruments that are to be used. 
Study materials will include study questionnaires, sleep diaries, measurement of anthropometrics, 
measurement of blood pressure, and a blood draw. Optional study materials will include wrist 
actigraphy via a Fitbit device, DEXA scan, and an at-home sleep test kit. 
 
III. HUMAN SUBJECTS 
 
1. Subjects 
a. Estimated maximum number of local site subjects: 40 
b. Estimated maximum number subjects at all sites (including local): 40 
c. Age(s) or Age Range: Aged ≥21 years 
d. Describe the Target Population: a description of the human subjects who will take part in 
the study, including members of both intervention/experimental and control groups, if 
relevant.  
Both the intervention and control groups will be comprised of Black adults diagnosed with 
invasive prostate cancer who have completed active cancer treatment, except for hormone 
therapy or maintenance therapy, and are experiencing symptoms of insomnia 
2. Study Duration for individual subjects 
Length of time involved in study. What is the actual burden of time for the individual subject? For 
example, 1 hour visits every year for a total of three years.   
Study enrollment will conducted over 4 months. Participants will take part in the study for a 
maximum of 12 weeks with two in-person 1-2 hour study visits that take place 10-12 weeks apart, 
in addition to completing 10 sleep diaries (~2 minutes to complete each). Participants in the 
intervention group will complete 6 Cores that are expected to take 45-60 minutes to complete over 
6-9 weeks, as well as 5 sleep diaries per Core in order to proceed to the next module (~2 minutes to 
complete each). 
3. Criteria for inclusion or exclusion 
a. What criteria will be used to include/exclude individuals in/from the study.  
Inclusion criteria: 
-Aged ≥21 years 
-Self-identifies as Black/African American 
-Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years 
-Completed active treatment (i.e., surgery, chemotherapy, radiotherapy) except hormone 
therapy or maintenance therapy 
-Has a smartphone, tablet, or computer with reliable internet access or willing to attend a 
weekly study appointment and to complete a weekly phone call 
-Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity 
Index) 
-Able to read and understand English 
 
Exclusion criteria: 
-Employed in an occupation where sleep restriction could be a harm to themselves or others 
(e.g., truck driver, operator of heavy machinery, pilot) 
-Actively employed in shift work 
-Diagnosed with a severe/major psychiatric disorder 
-Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure 
-Unable to consent 

 
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b. Are any of these criteria based on race or ethnic origin, age, or gender?  If so please explain 
and justify. 
This study is focused on Black prostate cancer survivors, who experience a disproportionate 
burden of prostate cancer incidence and mortality and insufficient representation in 
survivorship research.  
4. Vulnerable Groups 
The Common Rule at 45CFR 46.111(b), and FDA regulations at 21CFR56.111(b), require IRBs to 
give special consideration to protecting the welfare of particularly vulnerable subjects, such as 
children, prisoners, pregnant women, mentally disabled persons, or economically or educationally 
disadvantaged persons. 
a. Choose from the following list those vulnerable populations that will be included in this 
study.  Select ALL that apply. If you are not including vulnerable populations select 
“None”. 
☒ None (continue to question #5) 
☐ Pregnant women 
☐ Neonates (newborn less than 4 weeks old) 
☐ Children 
☐ Prisoners 
☐ Mentally disabled   
☐ Economically or educationally disadvantaged 
☐ Cognitively impaired 
☐ Subordinates to one or more investigator  
☐ Other:       
b. Justify the inclusion of any vulnerable population and why that population is being studied. 
n/a 
5. Subject recruitment.  
Recruitment of subjects must be free of undue influence and coercion.   
a. Select ALL recruitment methods that will be used. 
☐ Email 
 
☒ Recruitment Letter to Subjects (electronic or print) 
☒ Flyer 
☐ Record Review 
☒ Online/Social Media Advertisement 
  
☐ Newspaper or other Traditional Advertisement 
 
☒ Other: The research nurse at the Office of Minority Health and Health Disparities Research 
(OMH) will screen medical records from the MedStar Health network. 
b. Describe the recruitment methods, including (1) source of subjects; and (2) when, where, 
and how they will be recruited. Attach copies of recruitment materials, as applicable, in the 
“Recruitment materials” section of the electronic application.   
Clinic: The research nurse at the OMH will screen medical records from the MedStar 
Health network. The study team will mail invitation letters and study flyers to the home 
addresses or will e-mail invitation letters to the email addresses listed for potentially 
eligible patients and will conduct a follow-up telephone call within 2 weeks of the mailing. 
Interested survivors can also contact study staff for eligiblity screening. 
Community: OMH staff will interact with potentially eligible survivors at community 
outreach and education events. 
 
Clinic: The research nurse will screen electronic medical records for MedStar Health for 
potential eligibility based on cancer diagnosis (invasive prostate cancer), date of diagnosis 
(within 5 years), type and date of cancer treatment (completed active treatment except 
hormone therapy or maintenance therapy), age (≥21 years), race (Black/African American), 
and additional comorbidities (diagnosis of a severe/major psychiatric disorder, diagnosis of 
a seizure disorder, recent seizure). 
Community: OMH staff will distribute study flyers and introduce the study at OMH events. 
Interested survivors will contact study staff for eligibility screening.  
c. Describe any recruitment methods that are not under direct control of the local investigator 
(e.g., other site or collaborators are completing some or all of the recruitment methods). 

 
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n/a 
6. Subject Compensation.  
Any payment made must be reasonable in relation to the time and trouble associated with 
participating in the study. It cannot constitute an undue inducement to participate. 
a. Describe any plans to compensate subjects in either cash, gift cards or non-cash item (e.g., 
gifts, extra credit) including timing of the compensation. If you are not providing 
compensation state “N/A”. 
When objective data collection is not available, participants can receive up to $60 via gift 
card. This amount includes $30 for completeting each study visit and sleep diaries. At study 
visit #1, participants will receive a reloadable gift card or an e-gift card. Once study staff 
have confirmed completion of the sleep diaries, $30 will be added to the gift card. For study 
visit #2, $30 will be added to the gift card after study staff have confirmed completion of 
the sleep diaries. 
 
When objective data collection is available, participants can receive up to $100 via a gift 
card. This amount includes $30 for completing each study visit and sleep diaries, $25 for 
completing at-home sleep testing, and $15 for completing a DEXA scan. Participants who 
wear a Fitbit will be able to keep it after study visit #2. At study visit #1, participants will 
receive a reloadable gift card or an e-gift card. For participants who complete a DEXA 
scan, $15 will be added to the gift card. Once study staff have confirmed completion of the 
sleep diaries, $30 will be added to the gift card. For participants who participate in at-home 
sleep testing, $10 will be added to the gift card once study staff have confirmed receipt of 
the sleep kit. For study visit #2, $30 will be added to the gift card after study staff have 
confirmed completion of the sleep diaries. For participants who participate in at-home sleep 
testing after visit #2, $15 will be added to the gift card once study staff have confirmed 
receipt of the sleep kit. 
b. Describe any plans to reimburse subjects for travel or other expenses. If you are not 
providing compensation for travel or expenses state “N/A”. 
n/a 
7. Potential Risks.   
A risk is a potential harm that a reasonable person would consider important in deciding whether or 
not to participate in research.  Risks can be physical, psychological, sociological, economic, or 
legal, and include pain, stress, invasion of privacy, embarrassment or exposure of sensitive or 
confidential data.  All potential risks and discomforts must be minimized to the greatest extent 
possible, for example by using appropriate safety measures, monitoring, robust data security 
measures, and withdrawal of a subject if there is evidence of a specific adverse event. 
a. What are the risks or discomforts associated with each interaction, intervention or 
procedure in the study? Provide a description of the procedures performed to lessen the 
probability or magnitude of risk. For example, how will undue stress as a result of 
completing interviews or surveys be minimized? 
Tiredness - low to moderate probility, minimal to moderate magnitude; common experience 
related to sleep restriction required by CBT-I, will be minimized by excluding survivors for 
whom tiredness could pose a safety risk to themselves or others 
Bruising from blood draw - low probability, minimal magnitude; common experience 
related to venipuncture, will be minimized by calmly explaining the blood draw procedure, 
working as gently as possible, and, after the blood sample has been taken, applying gentle 
pressure to the puncture site in order to stop bleeding and minimize potential bruising 
Exposure to radiation from DEXA scan - high probability, minimal magnitude; inherent to 
the procedure, will be minimized by collecting data only at the enrollment visit 
Psychological discomfort - low probability, minimal magnitude; will be minimized by 
using electronic or hard copy study questionnaires, ensuring all staff have human subjects 
research training, by reiterating that survivors’ names will not be connected to their data 
and that only aggregate results will be presented in public, and by reminding participants 
that they can skip questions that they prefer not to answer 

 
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Loss of confidentiality - low probability, minimal magnitude; will be minimized by 
ensuring that all staff have human subjects research training, by following Georgetown 
policies for data management and confidentiality, and by requiring that participant data is 
treated like PHI by Wesper, Inc. and that this vendor maintains HIPAA compliance 
b. Describe whether disclosure of identifiable information about the subjects (even if 
unintentional or accidental) presents any additional risks to them (e.g., Criminal or civil 
liability, damage to financial standing, employability, or educational advancement or 
reputation, or relationships with other people [e.g., family relationships, 
employer/employee relationships, other]). 
It is possible that disclosure of identifiable information could present additional risks due to 
previously undisclosed information about the cancer diagnosis, symptom burden, and/or 
genetic information (if blood samples are assayed for genetic information in the future). 
However, it is anticipated that the risks would be minimal and primarily social/relational in 
nature. 
c. Describe any limitations on confidentiality based on possible reporting issues, for example, 
if the research team is likely to uncover child, elder or sexual abuse, neglect, or reportable 
diseases. Please note, the study team will need to disclose this information to appropriate 
authorities as required by the law.  
Note: Please be sure to have the consent form reflect this information as well. 
The research team is not likely to uncover reportable offenses or diseases. 
d. What follow-up efforts will be made to assess any harm resulting from your study, and 
under what circumstance would the IRB informed? 
No harms are anticipated to result from the study. However, if a participant's report or 
analysis of study data reveals an increase in symptom burden or any adverse event or 
unanticipated problem, these findings would be reported to the IRB. The Lombardi 
Comprehensive Cancer Center Clinical Trials Office Quality Control Unit evaluates 
protocol compliance and conducts audits of cancer-related clinical trials, which would 
provide additonal oversight of potential harms.   
8. Diagnostic Findings and Referrals 
Will referrals to counseling, community-based help or other intervention be offered to subjects if 
study participation could cause psychological risks or physical risks, if diagnostic findings reveal 
that a participant may need intervention or treatment, or if it is expected the participant would 
otherwise benefit from the referral?  Please describe why or why not.  If a document listing referrals 
or recommendations of sources of support are to be provided to participants, please include this 
document in your IRB submission.  
Study participation is not expected to cause psychological or physical risks and no incident 
findings from staff measurement, biospecimen assays, or at-home sleep testing is expected. 
9. Potential Benefits.   
• 
Describe the potential benefits to subjects or to others that may be reasonably expected to 
result from the research. If there is no potential for direct benefit, state this here and include 
in the informed consent/script. 
• 
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits and in 
relation to the importance of the knowledge that may reasonably be gained. Will the 
research study benefit future populations?  
• 
Compensation for involvement in the research cannot be considered a benefit. Please 
describe payment in Section 6 only. 
a. What potential benefits might the subjects receive from participating in the study?  
Participants may experience improvements in their insomnia symptoms and in non-
insomnia PROs. It is highly probable that participants who receive SHUTi and engage with 
the Cores will experience clinically relevant improvements in their insomnia symptoms that 
may last more than 6 months. Participants who complete at-home sleep testing may benefit 
from receiving a personalized report from the smartphone app that describes their sleep. 
This benefit is likely small and of short duration. 

 
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There may be no direct benefit to participants who are randomized to sleep education who 
also do not participate in at-home sleep testing. 
Given that anticipated risks are minimal and of low-moderate magnitude and that 
improvements in sleep may lead to improvements in other health outcomes, the risks to 
individual subjects are considered reasonable. 
b. What potential benefits might society expect from the study? 
SHUTi has demonstrated efficacy among breast cancer survivors and both the standard 
version of SHUTi and a culturally-tailored version of SHUTi demonstrated efficacy among 
middle-aged and older Black women. However, to date, this accessible and interactive 
intervention has not been investigated among prostate cancer survivors. Thus, the study 
could uncover opportunities to improve survivorship and possibly reduce racial disparities 
among prostate cancer survivors. This outcome would benefit future populations of cancer 
survivors and their communities. 
10. Subject Withdrawal 
Describe what will happen if subjects voluntarily withdraw from the research.  Specify the study 
milestone at which subjects can no longer withdraw (for example, after they click “submit” on the 
anonymous survey, or after the data is de-identified). Consider potential negative consequences of 
withdrawal that would require the participant to follow special procedures to reduce the risk of 
harm.  
We do not anticipate withdrawing participants from the study without their consent. The web-based 
intervention does not require orderly termination. Any participant who elects to withdraw can 
immediately discontinue accessing the web portal and contact study staff. Study staff will revoke 
the participant’s access to the web portal within 48 hours of confirming their request to withdraw 
from the study. However, if a participant withdraws after randomization, the data that they 
previously provided will contribute toward analyses. No special procedures are expected to be 
needed in order to reduce risk of harm from withdrawal. 
11. Data management and confidentiality 
Please review and complete Georgetown University Information Services (UIS) guidance and 
requirements found in Appendix A. Appendix A is a useful reference in completing this portion of 
the application.  
a. Briefly outline the data analysis that is proposed and who will do it. 
Preliminary statistical analysis will assess the distribution of the study variables at baseline 
and follow-up overall and by intervention group: means (and standard deviations) and 
medians (and ranges) for continuous variables and frequencies (and percentages) for 
categorical variables.  
We will compare the change in ISI score from the baseline study visit to the follow-up 
study visit in the intervention group vs. the control group. This analysis will assess mean 
change in ISI score, as well as insomnia response (i.e., >7 point reduction in ISI score) and 
insomnia remission (i.e., ISI score <8 at follow-up). 
We will also compare change in non-insomnia PROs from the baseline study visit to the 
follow-up study visit in the intervention group vs. the control group. 
All statistical analyses will use SAS 9.4 (SAS Institute Inc., Cary, NC) or R (R Foundation 
for Statistical Computing, Vienna, Austria). 
The preliminary statistical analyses will allow for the detection of outliers, duplicates, and 
missing data elements. Continuous variables with outliers can be categorized for analysis. 
Duplicates will not be included in the analyses. Missing variables that factor into indices, 
like the ISI, will result in a missing value for the index. The missing indicator method can 
be used for analyses. 
Statistical data analyses will be conducted by trained study staff, as appropriate (e.g., the PI, 
the biostatistician). 
b. Where will data be stored? Describe the steps taken to secure the data from the initial point 
of data collection to the ultimate storage location. Include where and how data will be 
collected and stored, for how long, who will be responsible for data security, and who will 

 
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have access. Will the data be moved in the course of the research?  Who (what role) is 
responsible for managing data integrity? 
All electronic data will be stored on our secure servers (GU Box) in a confidential fashion. 
Subjects will be identified by a study-specific identification number. Links between study 
ID numbers and identifying information will be password protected. Only the PI and 
authorized study staff will have access to this information for research purposes. Data will 
be directly stored in a database with daily network back-ups. Biospecimens will only be 
evaluated for research purposes and anyone who handles blood samples will not have 
access to identifying information. All samples will only be linked with a study-specific 
identification number and the date of the blood draw. 
 
All data collection reports and summaries will be kept in a locked file in the Office of 
Minority Health and Health Disparities Research. Access to these files will be limited to 
study team members as authorized by the Georgetown Institutional Review Board. 
Standard institutional safeguards to protect the data will be followed. All data will be kept 
in locked file drawers. Access to data files that contain identifying information will be 
secured with a password filing system and will be restricted to only approved study staff. 
All project file cabinets and databases will be secured and locked when not in use. 
 
The data will include variables describing participants’ questionnaire responses, objective 
data, and staff-administered measurements. Participants’ identifying information will be 
kept separately from their questionnaire and device data. Participant responses and 
objective data will be linked to individuals only through a unique identifier and the 
information used to link records with identifying information will be kept in a securely 
locked file cabinet only accessible to the study team. Electronic data will be stored in 
password protected databases on the secure Georgetown server and on Georgetown Box. 
Identifying information will not be included on datasets used for statistical analysis and 
study progress reports. 
 
Data collected from questionnaires will be stored on the REDCap database on the Lombardi 
server and exported to files stored on Georgetown Box; hard copies of completed 
questionnaires will be stored in labeled file folders in locked cabinets at the OMH. Data 
from the at-home sleep testing and actigraphy will be stored on Georgetown Box. 
Biospecimens will be stored frozen at the Tissue Culture & Bio-banking Shared Resource 
(TCBSR) laboratory. Data and biospecimens will be stored for up to 10 years after the end 
of the study. 
 
Access to the data will be restricted to the PI and study staff. Access to the biospecimens 
will be restricted to the PI, study staff, and TCBSR staff. The PI will manage data security 
and data integrity, with support from the biostatistician. 
 
Data from the at-home sleep kits will be transmitted via Bluetooth from participants' 
smartphones to the vendor's cloud-based storage system at stored for up to 2 years. Data 
will be provided to the study team, who will manage the at-home sleep test data alongwith 
other study data as described above. All study data will be deleted by the vendor at the 
Principal Investigators' request or after 2 years, whichever is earlier. Participants who 
complete at-home sleep testing will be asked to delete the smartphone application at the end 
of the study.  
c. If the data will be stored in a repository with the intent to share data with other researchers 
and/or use the data for future research, describe where and for how long the data will be 
stored, who can obtain the data, and how data release will be requested and provided.   
The data will not be stored in a repository. 
d. Which of the following describes the nature of the data (See Appendix B for definitions): 

 
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☒  The data will be associated with Personal Identifiers    
☐  The data will be deidentified but coded (a code links it to identifiers) 
☐  The data will be completely deidentified and not linked to identifiers  
☐  The data will be collected anonymously 
e. Explain the procedure you will follow, if any, to deidentify the data, and/or to code and 
record personal identifiers. 
A limited data set will be used for analyses. Codes linking participants’ identifying 
information with a study-specific identificaton number in the limited data set will be stored 
separately from the corresponding data sets. 
The data will only be accessed on Georgetown University workstations and lap tops such 
that encryption and password protection will be in place with two-factor authentication 
required for access. Access to the data is limited to the PI and study staff. Any study staff 
added to the project will be approved by the PI and added to the IRB protocol. 
Outside vendors – University of Virginia (SHUTi program), Fitabase/Small Steps Labs 
LLC (Fitbit data), Wesper, Inc.(at-home sleep testing) – will be used and subject to a 
security review and appropriate contracts and confidentiality agreements. Whereever 
possible, a study-specific and vendor-specific identification number will be used. For the 
at-home sleep test, each user account will use an anonymized username, email address, and 
password. Otherwise, only the minimum amount of personal identifiers required for use of 
outside vendors will be used. 
f. Will any of the identifiable data be Protected Health Information (PHI)? PHI needs to be 
deidentified in order to comply with HIPAA regulations. (Guidance on deidentification is 
available here.) 
Yes 
g. Describe any plans for sharing data outside the study team, including with whom and what 
will be shared. 
The PI will be responsible for receipt and transmission of the data. The project coordinator 
and TCBSR staff will be responsible for receipt and transmission of the biospecimens. Data 
sharing with service providers will be restricted to the service contract/scope of work. We 
do not anticipate additional data sharing.  
h. What will happen to the data when the study is completed? 
All Georgetown University policies and procedures for data collection, storage, 
transmission and destruction will be followed. 
12. Deception.  
If deception will be used to meet the objectives of the study you must clearly describe how the risks 
to subjects are reasonable in relation to the anticipated benefits. Explain how the study meets the 
conditions for waiver of alteration of full informed consent.   
Will the study use deception to achieve its objectives (deception includes withholding research 
purpose or design from subjects)?   
☐ YES  ☒  NO If yes, describe and justify. 
      
13. Consent Process  
Documented informed consent is a requirement for all non-exempt human subject research.  
Templates for informed consent are available on the GU IRB website.  Attach copies of the 
informed consent/assent materials in the Consent Form section of the electronic application. Under 
certain circumstances the committee may waive the requirement for informed consent. OHRP 
Informed Consent FAQs 

 
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a. Select the consent options you will use during the course of the study. Each selection below 
must have a description in the subsequent section(s). Choose all that apply: 
☒  Obtaining Signed Consent (Subject or Legally Authorized Representative) 
☐  Obtaining Consent Online (Waiver of Written Documentation of Consent ) 
☐  Obtaining Verbal Consent (Waiver of Written Documentation of Consent) 
☐  Obtaining Signed Parental Permission 
☐  Obtaining Signed Assent for Children or Adults Unable to Consent* 
☐  Waiving Consent and/or Parental Permission (Waiver of Consent Process) 
☐  Obtaining Verbal Assent for Children or Adults Unable to Consent 
☐  Waiving Assent (Waiver of Assent as Assent if Not Appropriate) 
☐  Other:       
*Assent is the agreement of a research subject who is not able to give legal consent to 
participate.  This is usually related to children under the age of 18 years old but can vary by 
state.  Additionally, assent may be appropriate for adults who are unable to consent for 
themselves.  Please see specific recommendation for assent of children and adults here:  OHRP 
Informed Consent FAQs 
b. Describe: 
 
Where the consent process will take place. 
 
Any waiting period available between informing the prospective subject, subject's 
Legally Authorized Representative (LAR), or subject's parent about the study and 
obtaining the consent/parental permission. 
 
The process for explaining to subjects new risks or study changes during the course 
of the study. 
 
What each individual involved in the consent process will do. (Do not include 
names of the individuals. For example, the study coordinator will provide an 
electronic copy of consent to subject via email and the PI will explain the study to 
the subject before proceeding with the intervention) 
 
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.  
The consent process will take place at the Office of Minority Health and Health Disparities 
Research. 
Survivors will be offered a 30 minute break to consider providing consent. Survivors will be 
invited to reschedule the study visit if they would prefer a waiting period of more than 30 
minutes. 
If new risks or study changes occur during the course of the study, the PI will seek IRB 
approval for revisions to the informed consent form and, if warranted, a letter to explain 
new risks and changes to participants and/or a form to re-consent participants in order to 
continue in the study. 
Survivors will arrive at their first study visit, at which time study staff (e.g., the project 
coordinator) will provide a paper copy of the informed consent form and wil explain the 
study to the subject. The staff member will describe the study goals and procedures, review 
the informed consent form, answer any questions asked, and ask the survivor whether they 
would like additional time to consider participating in the study prior to obtaining signed 
consent. A maximum of 1 hour will be devoted to the consent discussion, with an additional 
30 minute break if the survivor would like additional time to consider the study and ask 
questions. Participants who will be invited to complete at-home sleep testing will be 
provided an additional consent form and offered an additional 30 minute break after the 
consenting study staff member demonstrates the at-home sleep test kit and smartphone 
application. 
The 30 minute waiting period, the option to reschedule the study visit, and demonstration of 
the at-home sleep test will help reduce coersion and undue influence. In addition, modest 
compensation is offered to minimize the potential for financial coersion. 

 
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To ensure potential participants' understanding, consenting staff will thoroughly review the 
informed consent form(s) and answer all questions. 
 
c. For Studies that request an alteration or waiver of the informed consent process: 
If you requested an alteration or waiver of the consent process, including using electronic 
consent and not documenting written consent: Review the “CHECKLIST: Waiver or 
Alteration of Consent Process (HRP-410 and HRP-411 in the IRB system Library)” and 
provide sufficient information to justify all criteria needed for approval of a waiver or 
alteration of consent.  
☒ NA 
Describe justification: 
      
d. For studies that will include non-English speaking participants: 
 
Reference the IRB policy manual and Procedure MG.O-004.03 — Consenting 
Non-English Speaking Research Participants. 
 
Describe if subjects that speak a specific language are the target of the study 
recruitment. Indicate what languages are understood by prospective subjects and 
describe the process to ensure oral and written information will be provided in that 
language.  
 
If you will not target a specific population that speaks a foreign language but would 
like to use the short form process, should you encounter a non-English speaking 
participant, please describe the process you will follow.  
 
Describe the process you will use for interpretation and documentation of informed 
consent.  
 
Include a statement of certification translation or certificate of translation for all 
translated documents in the “other attachments” section of the electronic 
application. 
☒  NA 
Describe:       
e. For studies that include persons under age 18: 
 
Describe whether and how parental permission will be obtained and documented 
from both parents, one parent, or individuals other than parents who can provide 
permission. (see “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013)”.) 
 
Describe whether and how assent will be obtained and documented. 
☒  NA 
Describe:       
f. For studies that include cognitively impaired adults: 
 
Describe the process for determining whether an individual is capable of consent. 
☒  NA 
Describe:       
g. For studies that include adults who are unable to consent: 
 
Review HRP-417 Checklist for cognitively impaired adults, describe and justify all 
criteria required for approval of the inclusion of adults unable to consent.  
 
List the individuals from whom permission will be obtained in order of priority.  
☒  NA 
Describe:       
14. Return of Results  
Describe if you plan to return individual results to participants and under what circumstances will 
you or will you not return results. If you are not returning results, justify why. Address how you 
will handle any incidental findings.   
Participants who log in to the SHUTi web portal will receive the results from their sleep diaries; 
participants who use the at-home sleep test kit will be able to view their sleep reports in the 

 
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accompanying smartphone application; participants who use a Fitbit will be able to view their 
actigraphy data. Individual results from study questionnaires, measurement, or assays will not be 
returned to participants, as the benefit to the individual is unclear. We do not anticipate any 
incidental findings with clinical relevance. In the event that an incidental finding with clinical 
relevance is discovered, we will contact the IRB for permission to re-contact the study participant in 
order to provide the information. 
 
IV. COLLABORATING or MULTI-SITE STUDIES 
 
1. Is this study a Multi-site or Collaborative study?* 
☐ YES  ☒ NO  (if NO, skip remainder of questions) 
*Collaborating Institution(s) 
A Collaborating Institution is an institution engaged in portions of the outlined research 
project. 
*Multi-site Study 
A multi-site study is a study which follows a single protocol but is conducted in more than 
one place, each of which is under the direction of one or more separate investigators. 
(Please Note: A study that utilizes one or more Research Locations at your institution 
would likely not be considered a multi-site or collaborative research study in this system. 
Please contact the IRB office for any questions about your study scenario.) 
2. Name of Collaborating Institution(s) and/or Site(s) for Multi-Site Studies 
List each collaborating institution or Multi-Site Study and indicate the corresponding activities 
conducted there with the appropriate letter(s) from the list below: 
A. The entire protocol will be conducted at the site outside GU (if this is selected no other letters 
need to be added) 
B. Obtain information by intervening or interacting with living individuals for research purposes 
C. Obtaining identifiable private information about living individuals 
D. Obtaining the voluntary informed consent of individuals to be subjects 
E. Making decisions about subject eligibility 
F. Studying, interpreting, or analyzing identifiable private information or data/specimens for 
research purposes 
G. Studying, interpreting, or analyzing coded (linked) data or specimens for research purposes 
H. Other: please specify      
 
EXAMPLE: 
Name: XZY University                                
Research Activities: B, E, H-the collaborator will recruit participants by review of the EMR 
at their site and provide to the PI at GU  
1. Name of institution:                                                            
Research Activities:       
2. Name of institution:                                                          
Research Activities:       
3. Name of institution:        
Research Activities:       
 
 
 

 
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APPENDIX A 
 
INFORMATION SERVICES GUIDANCE ON DATA STORAGE AND SECURITY 
 
Please complete the following checklists from Georgetown University Information Systems. 
Definitions of Terms are included below the checklist for your reference and accurate completion.   
 
Indicate in the chart below what type of data is being collected, stored, transmitted, and/or 
shared.  
 
Collected 
Stored 
Transmitted 
Shared 
Protected Health Information (PHI) 
☒ 
☒ 
☒ 
☒ 
Personally Identifiable Information 
(PII) 
☒ 
☒ 
☐ 
☐ 
Identified 
 
☒ 
☒ 
☐ 
☐ 
Deidentified (includes no PHI or PII) 
 
☐ 
☐ 
☐ 
☐ 
Limited Data Set (LDS 
 
☒ 
☒ 
☒ 
☒ 
Data from vulnerable populations* 
 
☐ 
☐ 
☐ 
☐ 
* Pregnant Women, Neonates, Children, Prisoners, Mentally Disabled, Cognitively Impaired, 
Economically or Educationally Disadvantaged 
 
 
Address the following data security questions.  All “NO” responses require further explanation 
as to why data security requirements are not being met. 
 
YES 
NO 
NA 
Computer software is in place to protect against malware (GU employees can visit 
Georgetown University Software Webstore to ensure you have the appropriate 
software) 
☒ 
☐ 
☐ 
All operating systems and software updates and patches are applied regularly 
☒ 
☐ 
☐ 
Data collected is only the minimum data necessary to answer the research 
question 
☒ 
☐ 
☐ 
Codes are stored separately from the corresponding de-identified data 
☒ 
☐ 
☐ 
Encryption and password protection are in place on all portable devices used to 
access data 
☒ 
☐ 
☐ 
Two Factor Authentication is used for all systems accessing research data 
☒ 
☐ 
☐ 
Any external service/supplier contracts and data use agreements have been 
reviewed and approved by appropriate institutional offices. 
☐ 
☒ 
☐ 
Physical and technical safeguards in place for electronic and paper data during 
collection, storage, transmission and destruction must be in alignment with 
Georgetown University/Medstar policies and procedures 
☒ 
☐ 
☐ 
Email will not be used to collect, store or transmit sensitive human subject 
research data or Protected Health Information (PHI) 
☒ 
☐ 
☐ 
Secured, non-public Wi-Fi will always be used with this data 
☒ 
☐ 
☐ 
Computer screens will be locked when not in use 
☒ 
☐ 
☐ 
Data will be securely destroyed at the end of the retention period. (GU policy on 
secure data destruction) 
☒ 
☐ 
☐ 

 
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Explain any “NO” responses here: Contract and agreement have been executed for University of 
Virginia; others are pending. 
 
Georgetown University Specific Policies 
 
 
YES 
NO 
NA 
For surveys, Qualtrics and RedCap– the GU approved survey systems for which 
we are licensed – will be used. 
☒ 
☐ 
☐ 
GU Box will be used as the data storage repository for Research Data 
☒ 
☐ 
☐ 
Data will be shared via GU Box or another secure method such as Secure File 
Transfer Protocol (SFTP).  Data will be encrypted during transmission. 
☒ 
☐ 
☐ 
I have read and will comply with the UIS Research Data Protections Guidelines 
☒ 
☐ 
☐ 
Explain any “NO” responses here:       
 
 

 
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APPENDIX B 
 
DEFINITIONS 
 
 
Protected Health Information (PHI): 
 
Protected health information includes all individually identifiable health information, including 
demographic data, medical histories, test results, insurance information, and other information 
used to identify a patient or provide healthcare services or healthcare coverage. ‘Protected’ means 
the information is protected under the HIPAA Privacy Rule. Protected health information is 
defined in the Code of Federal Regulations and applies to health records, but not education records 
which are covered by other federal regulations, nor records held by a HIPAA-covered entity 
related to its role as an employer. In the case of an employee-patient, protected health information 
does not include information held on the employee by a covered entity in its role as an employer, 
only in its role as a healthcare provider. 
 
PHI does not include individually identifiable health information of persons who have been 
deceased for more than 50 years. 
Below is the list of 18 identifiers defined by federal regulations: 
 
1. 
Names; 
2. 
All geographical subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a 
zip code, if according to the current publicly available data from the Bureau of the 
Census: (1) The geographic unit formed by combining all zip codes with the same three 
initial digits contains more than 20,000 people; and (2) The initial three digits of a zip 
code for all such geographic units containing 20,000 or fewer people is changed to 000. 
3. 
All elements of dates (except year) for dates directly related to an individual, including 
birth date, admission date, discharge date, date of death; and all ages over 89 and all 
elements of dates (including year) indicative of such age, except that such ages and 
elements may be aggregated into a single category of age 90 or older; 
4. 
Phone numbers; 
5. 
Fax numbers; 
6. 
Electronic mail addresses; 
7. 
Social Security numbers; 
8. 
Medical record numbers; 
9. 
Health plan beneficiary numbers; 
10. 
Account numbers; 
11. 
Certificate/license numbers; 
12. 
Vehicle identifiers and serial numbers, including license plate numbers; 
13. 
Device identifiers and serial numbers; 
14. 
Web Universal Resource Locators (URLs); 
15. 
Internet Protocol (IP) address numbers; 
16. 
Biometric identifiers, including finger and voice prints; 
17. 
Full face photographic images and any comparable images; and 
18. 
Any other unique identifying number, characteristic, or code (note this does not mean 
the unique code assigned by the investigator to code the data) 
 
 
Personally Identifiable Information (PII): 
The term “personally identifiable information” refers to information which can be used to 
distinguish or trace an individual's identity, such as their name, social security number, biometric 
records, etc. alone, or when combined with other personal or identifying information which is 
linked or linkable to a specific individual, such as date and place of birth, mother’s maiden name, 
etc. (OMB, 2007) 
 

 
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PII can also be a combination of data from which, taken together, the identity of a person can 
reasonably be known. For example, if the complete birthdate is given as well as the gender, then 
even the school or street location would be enough to link information provided in a study about 
an individual to the specific individual.  A study subject might disclose private information as part 
of the study, and/or a study test result might generate private information.  In some Human 
Subjects Research studies, the only identifying information is the consent form or, even without a 
consent form, the identifying information is that co-subjects in the study observe private 
information about another co-subject.  
 
PII is protected by state and local data breach laws, and includes: 
 
o Social Security Number 
o Place of Birth 
o Dependents 
o Bank account numbers 
o Income tax records 
o Driver’s license numbers 
o Credit card numbers 
o Passport numbers 
 
 
Anonymous Data : 
Data that was collected without identifiers and that were never linked to an individual. Coded data 
are not anonymous.  
 
 
De-identified Data : 
The term “de-identified” or “anonymized” should be used only to describe data that: 
 
Previously contained identifiers, which have been stripped, and no “code” linking the data 
back to identifiers still exists, such that the dataset cannot be “re-identified” by anyone. 
 
Data is not “de-identified,” but “coded” and “indirectly identifiable” if: 
 
Researchers have “coded” the data and store the code separately from the research dataset, 
or the data provider has the “key” to “coded” data, even if the researchers do not, or 
anyone can “re-identify” the data by linking the dataset to direct identifiers. 
 
 
Limited Data Set: 
A Limited Data Set is a set of data in which 16 categories of identifier have been removed.  
 
The following identifiers of the study subjects, or of the study subjects’ relatives, employers or 
household members, can be included in a limited data set:  
 
1. All elements of dates, such as birth date, admission date, discharge date, and date of 
death; 
2. Town or city, state, and ZIP Code 
 
The following identifiers of the study subjects, or of the study subjects’ relatives, employers or 
household members, must be removed from a limited data set: 
1. 
Names; 
2. 
Addresses, other than town or city, state, and zip code; 
3. 
Telephone numbers; 
4. 
Fax numbers; 
5. 
Electronic mail addresses; 
6. 
Social security numbers; 
7. 
Medical record numbers; 
8. 
Health plan beneficiary numbers; 
9. 
Account numbers; 

 
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10. 
Certificate / license numbers; 
11. 
Vehicle identifiers and serial numbers (including license plate numbers); 
12. 
Device identifiers and serial numbers; 
13. 
Web Universal Resource Locators (URLs); 
14. 
Internet Protocol (IP) address numbers; 
15. 
Biometric identifiers, including finger and voice prints; and 
16. 
Full face photographic images and any comparable images.