Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
Phase: NA
Conditions: Insomnia, Insomnia Due to Medical Condition, Cancer
Sponsor: Dana-Farber Cancer Institute

 
 
 
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): 
An Online Educational Intervention for Insomnia 
 
Protocol and Analysis Plan 
 
 
NCT # 05358951 
 
Dana-Farber Cancer Institute IRB approval date 9/20/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PI: Christopher Recklitis, PhD, MPH 
Dana Farber Cancer Institute 
 
TABLE OF CONTENTS 
1.0 
INTRODUCTION ............................................................................................................... 2 
1.1 
Background ...................................................................................................................... 2 
1.2 
Overview ........................................................................................................................... 3 
2.0 
AIMS ................................................................................................................................... 4 
3.0 
PATIENT SELECTION ...................................................................................................... 4 
3.1 
Eligibility Criteria ............................................................................................................ 4 
3.2 
Exclusion Criteria ............................................................................................................ 4 
4.0 
RECRUITMENT ................................................................................................................. 5 
5.0 
STUDY DESIGN AND METHODS................................................................................... 7 
5.1 
Study Design ..................................................................................................................... 7 
5.2 
Methods ............................................................................................................................ 7 
5.3 
STEP-YA Intervention ...................................................................................................... 9 
5.4 
Behavioral Coaching ...................................................................................................... 11 
5.5 
Study Measures .............................................................................................................. 11 
5.6 
OnCore Registration ...................................................................................................... 13 
6.0 
RISKS AND ADVERSE REACTIONS AND THEIR MANAGEMENT ....................... 13 
7.0 
STATISTICAL ANALYSIS ............................................................................................. 15 
8.0 
REFERENCES .................................................................................................................. 17 
 
APPENDICES 
Appendix A 
Recruitment Materials 
Appendix B 
Measures 
Appendix C 
Participant Correspondence & Phone Scripts  
Appendix D 
STEP-YA Session Materials 
Appendix E 
Coaching Session Script 

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1.0 
INTRODUCTION 
1.1 
Background 
Young adult cancer survivors (YACS) are particularly vulnerable to treatment late-effects 
including insomnia.1-8 Insomnia is often viewed “as a temporary reaction to the cancer diagnosis 
or treatment,”9 with few long-term consequences, but insomnia frequently develops into a 
debilitating chronic condition. As many as 1 in 4 YACS experience significant insomnia even 
many years after cancer treatment.5-7, 10  Chronic insomnia is associated with significant health 
problems, including heart disease, obesity, hypertension, diabetes, depression, and anxiety.11-20 
Because of their cancer treatments, YACS are already vulnerable to many of these health 
conditions, making access to effective insomnia treatment critically important to their overall 
health.21-23  
Cognitive-behavioral therapy for insomnia (CBTI) is a well-established and empirically 
supported treatment. Multiple randomized trials have demonstrated it is the most effective long-
term insomnia treatment, even compared to pharmacotherapy.24-26 A review of CBTI for cancer 
survivors similarly concluded it “provides significant, lasting improvement.”27 Unfortunately, 
despite compelling evidence, this empirically validated treatment is largely unavailable to the 
growing population of YACS who need it.28, 29 To make CBTI widely available to YACS, 
several barriers need to be resolved, including the shortage of trained CBTI providers,30, 31 the 
high burden of standard CBTI regimens,32 33 and the lack of CBTI interventions specifically 
targeting the needs of YACS. Moreover, as the ongoing COVID-19 pandemic presents 
considerable health risk for cancer survivors,34 it is imperative CBTI be delivered using methods 
that minimize risk of exposure.  
To address these challenges and deliver effective insomnia treatment to YACS, we have 
developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-
YA), a brief low-intensity intervention presenting essential elements of CBTI in an online 
educational format. Delivered in a 90-minute, 1 on 1, instructor-led session, STEP-YA educates 
YACS about causes of insomnia after cancer, including developmental, social, and health factors 
affecting YACS, and introduces them to CBTI principles and methods. Following a self-
management approach, the instructor provides guided behavioral planning encouraging survivors 
to develop an individualized sleep action plan they will implement after the session. STEP-YA 

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targets YACS’ specific needs and experiences and supports their autonomy by helping them 
make informed choices to manage their own insomnia.35  
STEP-YA builds on our previous work successfully developing novel CBTI interventions for 
cancer survivors, including brief educational interventions, synchronous and asynchronous 
online interventions, and targeted interventions for YACS.36-39 Based on results showing low-
intensity CBTI interventions are potent enough to significantly improve insomnia in cancer 
survivors, we have developed STEP-YA to meet the needs of the majority of YACS with 
insomnia for whom standard CBTI is not appealing, not available, or not needed. Guided by the 
ORBIT model40, 41 for development and early testing of behavioral interventions, we now plan 
this Phase I/II optimization trial (cites) to refine and preliminarily test the STEP-YA 
intervention. 
1.2 
Overview 
This study will evaluate STEP-YA in an RCT of 74 off-treatment YACS (ages 20-39). As 
individualized coaching is an effective component of behavioral interventions for cancer 
survivors and other populations,42-44 we are interested in evaluating their utility for supporting 
STEP-YA outcomes. Study participants will be assigned (1:1) to receive the STEP-YA 
intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote 
coaching sessions (coaching condition). STEP-YA sessions will be delivered online using the 
Zoom platform, which is currently in use at DFCI for virtual patient visits and education 
programs. Participants will complete measures of insomnia and mood at baseline and again at 4- 
and 8-weeks post-baseline. A repeated-measures design, with each subject acting as their own 
control, enables the trial to efficiently evaluate potential efficacy of STEP-YA (phase IIa “proof 
of concept” objective). Randomization to a coaching condition makes it possible to the evaluate 
utility of remote coaching to improve STEP-YA outcomes (phase Ib objective). As coaching 
sessions add significantly to costs and complexity, a goal of this study is to determine if they 
have potential to augment STEP-YA effects before including them in any future Phase III 
efficacy trials of STEP-YA.  
 
 

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2.0  
AIMS 
1. To test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) and 
mood (secondary outcome) in young adult cancer survivors. 
2. To determine if improvement in these outcomes are superior in the coaching condition 
compared to the non-coaching condition.  
A secondary aim will be to explore participant factors associated with clinically significant 
response to the STEP-YA intervention.  
 
3.0 
PATIENT SELECTION 
3.1 
Eligibility Criteria  
To be determined by patient self-report from eligibility screening with potential participants. 
(See Appendix A for eligibility screening materials). Participants must be screened for eligibility 
≤2 weeks prior to study enrollment.  Participants who are screened earlier must be rescreened 
within this period. ISI scores are valid for 4 weeks, only rescreen with ISI if  > 4 weeks since 
initial screening. 
• Age 20-39 
• History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior 
• No active cancer therapy (excluding chemoprevention) in the past four months, and 
no further therapy planned  
• Significant insomnia as evidenced by an Insomnia Severity Index score ≥12  
• Able to read and write in English 
3.2 
Exclusion Criteria 
• Survivors who report ever being diagnosed with Bipolar Disorder. 
• Survivors who report ever being diagnosed with a Seizure Disorder or have 
experienced a seizure in the past 12 months. 

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• Intention to adjust (decrease or increase) use of any prescribed or over-the-counter 
medications taken to decrease insomnia during the study period. 
• Survivors who report being diagnosed with sleep apnea who are not receiving 
recommended medical treatment for their sleep apnea (as assessed by screening 
questions, see Appendix A). 
• Survivors who report suspected sleep apnea who have not completed an evaluation by a 
sleep specialist (as assessed by screening questions, see Appendix A). 
• Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am. 
• Employment that involves irregular sleep patterns, such as shift-work or frequent 
long-distance travel across time zones, or employment in a position that could impact 
public safety (such as air traffic-controller, operating heavy machinery) 
• Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to 
complete all study procedures independently. 
• Prior participation in a research study which provided an educational or behavioral 
intervention for insomnia 
• Prior participation in a behavioral treatment or patient education program for 
insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children’s 
Hospital. 
• Participation in behavioral or educational interventions for insomnia in the 2 years 
prior to enrollment. This includes in-person as well as synchronous and asynchronous 
online insomnia programs, but not independent use of books, workbooks or other 
written self-help materials addressing insomnia.    
 
4.0 
RECRUITMENT 
This study will follow procedures currently in place for other survivorship interventions which 
recruit from multiple clinics at DFCI (17-515, 17-402) in order to identify potentially eligible 
survivors for recruitment purposes. Recruitment procedures for this study are identical to Dr. 
Recklitis’ recently approved study testing a version of the Sleep Treatment Education Program 

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for older survivors (DFCI 20-516). All procedures have been developed in consultation with the 
disease centers and have proven to be effective and non-burdensome for clinicians and patients, 
while ensuring that only survivors appropriate for recruitment are approached.  
Dr. Recklitis will work with each participating clinic’s leadership to determine how each clinic 
wishes to make their patients aware of the study, and develop specific procedures for each clinic 
or disease center. As in our past studies, the survivorship research coordinator will typically 
function in the same manner as the clinic’s research coordinators, working with the clinicians to 
determine appropriate patients and timing for providing study information to potential 
participants.  Additionally, each clinic will determine an appropriate clinician or clinicians to co-
sign the recruitment letter/email, as seen in the recruitment materials provided in Appendix A. 
After getting permission to approach potential subjects from their medical provider, subjects will 
be approached, screened for eligibility, and recruited by a member of the study staff. 
Recruitment materials and a study information sheet can be found in Appendix A.  While this 
could occur in person at a scheduled clinic visit, as survivorship visits are frequently conducted 
as telehealth visits, it is anticipated that some  survivors will be contacted by telephone, 
videoconference, email, or mail. Templates for all of these recruitment methods can be found in 
Appendix A. 
Eligible survivors will also be identified from Project REACH (DFCI 07-134; Dr. Recklitis, PI), 
a cohort study of survivors followed at DFCI. Project REACH participants complete annual 
surveys of physical and emotional health and have consented to these surveys being used to 
determine eligibility for other survivorship studies.   
To identify eligible participants, we will work directly with the administrative and clinical staff 
in participating clinics and programs, and we will also use administrative data sources including 
EPIC, OncDRS, and CORIS.  We are requesting a Waiver of Authorization to identify eligible 
participants. Subjects will be screened in person, by telephone, or videoconference using the 
eligibility screen, including the ISI scale (see Appendix A).   
Potential subjects may also be referred by a Dana-Farber clinician or self-refer to the study.  To 
ensure that potentially interested YACS are aware of the study, investigators will collaborate 
with survivorship education and support programs both affiliated with DFCI, and those in the 
community.  Specifically, these programs will be asked to inform their members about the study; 

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a brief advertisement suitable for use in patient newsletters, advocacy group newsletters or 
websites can be found in Appendix A. Similarly, as social media has been found to be a highly 
successful recruitment tool for YA cancer survivors, we will utilize social media popular with 
this cohort (e.g. Reddit, Facebook, Twitter, IG);  a sample social media post can be found in 
Appendix A.  A study website (STEPforSleep.com) will contain IRB-approved  information 
about the study including contact information for the study team, the study information sheet, a 
link to the study on Clinical Trials.gov, and the video advertisement (see Appendix A).  The 
study will also have a Facebook page, as well as Instagram and Twitter accounts which will 
direct potential subjects to the study web site.  To promote the study to potentially interested 
cancer survivors, study staff will periodically post on these sites (see Appendix A for sample 
posts). 
5.0 
STUDY DESIGN AND METHODS 
5.1 
Study Design 
This study is a randomized controlled trial of 74 young adult cancer survivors with clinically 
significant symptoms of insomnia, randomized to the STEP-YA intervention with or without 2 
remote coaching sessions. All participants will take part in a single STEP-YA session, during 
which they will complete baseline measures prior to receiving the STEP-YA intervention. 
Following the intervention session, they will be randomized to the coaching or non-coaching 
conditions. Participants will complete follow-up measures 4 and 8 weeks post-baseline.  
5.2 
Methods 
See section 5.5 for descriptions of all study measures.  Copies of the assessments can be found in 
Appendix B, and participant correspondence in Appendix C. 
Informed Consent: We are requesting a Waiver of Documentation of Informed Consent for this 
study, as it is a minimal risk study involving no procedures (questionnaires and educational 
session) for which signed consent is generally required outside of the research context.  The 
intervention sessions in this study are similar to educational sessions currently conducted through 
the Blum Center at DFCI, and for which no signed consent is required. A similar online 
intervention currently being conducted by Dr. Recklitis (17-515) was granted a waiver of 
documentation of consent, and we propose to utilize those approved consent procedures for this 

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study.  Potential participants will be provided with a study information sheet which contains all 
the elements of informed consent (See Appendix A), and will have a consent conversation with a 
member of the study staff in which they can ask questions about the study or study procedures 
before providing verbal consent.  As it is anticipated that many off-treatment survivors will not 
have in person clinic visits at DFCI for the foreseeable future, it is expected that most of these 
consent conversations will take place by telephone or videoconference, although they could be in 
person if requested. 
Intervention session: After expressing interest, participants will be scheduled for an individual 
videoconference intervention session.  The intervention session consists of the following 
components: 
1) Informed Consent: Study staff will review the study procedures and the Study Information 
Sheet with the participant and answer any questions they may have.  They will then obtain 
verbal consent. (Verbal consent procedures can be found in Appendix C) 
2) Baseline measures: Study staff guide participants in completing baseline measures 
including insomnia and mood using the Qualtrics web-based survey platform.45 Participants 
enter data directly into the system, and the study staff do not collect data from participants.   
3) Intervention Delivery.  After completing baseline measures, the participant will 
immediately receive the STEP-YA intervention session via videoconference. (See section 
5.3 for a description of the STEP-YA intervention). During the session, both the participant 
and the interventionist will be blinded to whether the participant has been randomized to 
receive the coaching sessions. 
4) Randomization: After completing the session, randomization will be performed using 
Sealed Envelope, a commercially available  online software application for randomising 
patients into clinical trials. Participants  will be randomized (1:1) to either: 1) STEP-YA 
alone (non-coaching condition) or 2) STEP-YA with the addition of 2 remote coaching 
sessions (coaching condition). Participants will then be informed of whether they were 
randomized to receive the coaching sessions, and will schedule their first telephone call 
(first coaching session for those in the coaching condition or 4-week follow-up for those in 
the non-coaching condition). Additionally, participants will be asked to provide preferences 
for all future contact and correspondence (i.e., phone, email, send secure, text, mail) and 

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these preferences and addresses/phone numbers will be recorded in the participant’s record.  
5) Session evaluation: Participants will receive a link to a questionnaire on which they will 
report on ease of use and acceptability, satisfaction, and credibility of the session.  To 
promote completion of the questionnaire, participants will be encouraged to complete it 
while still in the Zoom session, but can choose to complete it at a later time.  Participants 
will receive a $10 gift card upon completion of this evaluation.  
Coaching Sessions: Participants randomized to the coaching condition will receive 2 
individualized remote coaching sessions 1, and again 2 weeks following their STEP-YA session. 
(See section 5.4 below for a description of the coaching sessions and timing). 
Post-intervention Follow-up:  At 4- and 8-weeks post-baseline, study staff will recontact 
participants by telephone at previously scheduled times, ask them to enter follow-up data directly 
into Qualtrics, and provide technical assistance if needed. Participants who cannot complete the 
full assessment at that time due to time constraints will be asked to complete the 7-item ISI 
(primary outcome measure) verbally and their responses will be collected; they will then be 
asked to complete the full questionnaire at their earliest convenience.   Participants will receive 
emailed reminders in advance of each phone call. At the 4-week call, participants will schedule a 
phone call for the 8-week assessment. 
Incentive: Participants will receive a $25 Amazon gift card upon completion of each follow-up 
assessment. 
Optional 16-week ISI: At the time of their 8-week follow-up phone call, participants will be 
asked if they would be willing to complete an additional sleep checklist two months later.  
Participants who agree will receive a Qualtrics link to the 7-item ISI 8 weeks later by email.  
This would take approximately 1-2 minutes to complete, and participants will not receive an 
incentive for this optional checklist. The link would be sent again a week later for non-
responders, but participants will receive no additional reminders. 
5.3 
STEP-YA Intervention  
STEP-YA is delivered in a single 90-minute synchronous videoconference session using HIPAA 
compliant Zoom technology46-48 licensed to our cancer center. Interventionists with graduate 
level training in psychology, social work, or closely aligned discipline (e.g., human development, 

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nursing) will be trained and supervised by psychologists with CBTI expertise to deliver the 
STEP-YA intervention following a structured outline. The interventionist will deliver STEP-YA 
in a 1 on 1 session using a slide deck of 47 slides and following a structured outline. During the 
session, the participant is able to see and hear the presenter, view the presentation slides, and ask 
questions. To support participants in developing and implementing their sleep action plan, take-
home materials including a copy of the presentation slides and sleep action plan template are 
provided by email. The presentation begins with educational information on the problem of 
insomnia after cancer and the 3-P model before presenting specific suggestions for improving 
sleep in YACS. These suggestions are based on CBTI components of sleep hygiene, stimulus 
control, and cognitive restructuring.27, 32, 49-51 To aid comprehension, this material is presented in 
four sections addressing 1. Lifestyle issues, (e.g., benefits of exercise and limiting alcohol), 2. 
Sleep environment (e.g., importance of a dark, quiet bedroom; avoiding bed for non-sleep 
activities), 3. Sleep timing (e.g., regular wake time, avoiding napping) and 4. Managing 
expectations and challenges (e.g., sleep worry, physical symptoms, social pressures). For each 
suggestion, an underlying rationale and potential benefit are presented. Both the look and content 
of the STEP-YA material are targeted to appeal to YACS. For example, text describing the 
benefits of exercise are accompanied by photos of young adults engaged in traditional and 
contemporary exercises, (e.g., yoga, spin class, cross-fit), and the description of the effects of 
caffeine includes photos of products YACS commonly consume (e.g., energy drinks, green tea, 
sodas, coffee drinks). In section 4, examples of the social, developmental and health challenges 
that YACS may encounter are noted, along with suggestions for managing them. These include 
living spaces shared with roommates or parents, social pressures, “fear of missing out,” and 
tendency toward a delayed sleep phase common in young adults, as well as physical health 
symptoms such as pain, or hot flashes. At the conclusion of each section (e.g., lifestyle), the 
participant is asked to review the suggestions in the section and complete their sleep action plan 
template to record their current sleep practices and behavioral changes they intend to make. 
Action plans of this kind are central to self-management education35 and have been shown to 
increase successful behavior change.52, 53 To close the session, the presenter offers examples of 
STEP-YA suggestions implemented in a daily routine, and asks the participant to review and 
revise their sleep action plan, including anticipating challenges and planning strategies to 
manage them.  

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5.4 
Behavioral Coaching 
Participants randomized to the coaching condition will receive 2 individualized remote coaching 
sessions 1, and again 2 weeks following their STEP-YA session. Optimal timing for coaching 
sessions is 7 and 14 days after the STEP-YA session, but may be scheduled between 5-23 days 
after the STEP-YA session with at least 5 days between coaching sessions. Paraprofessional 
coaches trained and supervised by psychologists with CBTI expertise will follow a structured 
outline adapted from a previous self-management intervention at our center.54 In the sessions, 
designed to last approximately 30 minutes, coaches ask participants to review their progress and 
challenges implementing their sleep action plan. Coaches offer support and encouragement and 
may refer participants to the take-home materials to help answer questions and reinforce program 
goals and suggestions. Following, principles of self-care management and previous coaching 
interventions sucesssful with cancer survivors,44, 55-58 coaching sessions are not prescriptive, but 
support YACS to use self-management skills including decision-making, goal-setting, self-
assessment, and problem solving to help them implement their individual sleep action plan.  
Administrative data on coaching session duration, and sessions missed, interrupted, or 
rescheduled will be collected.  
 
5.5 
Study Measures 
All measures were previously used with cancer survivors on DFCI 15-336.  Measures can be 
found in Appendix B. Measures are given at all timepoints unless otherwise noted. 
The Insomnia Severity Index (ISI)59: The 7-item ISI is the most commonly used measure in 
insomnia research and has been validated in cancer populations.60 It has demonstrated adequate 
internal consistency, and is sensitive to detect changes in perceived sleep difficulties with 
treatment.   
Profile of Mood States – Short Form (POMS-SF)61: The Profile of Mood States-Short Form is a 
commonly used measure of psychological distress that has been validated in cancer 
populations.62 It is a 35-item measure which assesses the mood states of participants, and 
provides multiple scales including an overall Total Mood Disturbance (TMD) score used here.  

12 
 
 Physical Health: Physical health will be assessed with one item from the commonly-used SF-
1263 asking respondents to rate their overall health. Pain will be measured with the commonly 
used Pain Thermometer64 on which participants rate their pain on a scale of 1-10, and a single 
item asking participants to rate whether they feel “in pain” on a five-point scale. 
 Sleep Treatment Change: Participants will be asked to report any changes made in sleep 
behaviors during the study period including those not specifically recommended by the study 
interventions (e.g., new sleep medications, new non-study meditation class). This measure is 
only completed at post-intervention timepoints. 
Demographics and Medical History: Demographic information, medical information (e.g., 
cancer diagnosis and treatment, recent psychiatric treatment), and insomnia history (e.g., 
insomnia duration, burden, past treatments) will be collected by direct patient report. The 5-item 
Morningness-Eveningness Questionnaire (Reduced)65 will also be included to identify 
participants’ circadian tendencies. This measure is only given at baseline.   
Intervention Evaluations: Participants will complete evaluations at several timepoints. 1) At the 
end of the intervention session, participants will report on ease of use and acceptability using 
checklist items adapted from the Telehealth Usability Questionnaire66 and satisfaction will be 
assessed with checklist items adapted from Dr. Recklitis’s previous survivorship education trials. 
2) Participants who are randomized to the coaching condition will complete a brief satisfaction 
evaluation of the coaching sessions after the second coaching phone call.  3) All participants will 
complete a brief questionnaire to provide their feedback about the intervention and how it could 
be improved at the 8-week post-intervention timepoint. 
Steps to insure complete data:  Participants will complete baseline measures online using 
Qualtrics at the intervention session prior to randomization to insure completeness. Following 
procedures found to be effective in Dr. Recklitis’ DFCI protocols 17-515, 15-336 and 14-583, 
the study also makes use of scheduled telephone appointments to insure timely completion of the 
follow-up assessments. In previous intervention studies, telephone appointments have been 
highly effective for encouraging survivors to complete assessments; we have achieved 100% 
complete data for primary endpoints and 95% complete data overall using this method. 

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5.6 
OnCore Registration 
As per DF/HCC SOP REGIST-101A, with the approval of the Director of the Office of Data 
Quality, retrospective registration will be utilized for this minimal risk study. 
Institutions will register eligible participants in the Clinical Trials Management System (CTMS) 
OnCore as required by DF/HCC SOP REGIST-101. When required by REGIST-101, registration 
must occur prior to the initiation of protocol-specific procedures or assessments.  
Registration requires a signed informed consent document and a completed eligibility checklist 
according to DF/HCC SOP REGIST-104. 
 
6.0 
RISKS AND ADVERSE REACTIONS AND THEIR MANAGEMENT 
Potential for some participants to experience increased daytime fatigue from the study 
intervention 
The primary risk of this minimal risk study for participants is a brief (1-2 week) period of 
daytime fatigue, which is the result of sleep scheduling (i.e., reducing daytime sleep).  
Consequently, participants may experience some physical and mental side effects associated with 
sleepiness.  However, these side effects should be similar to the effects of sleepiness they have 
previously experienced due to their insomnia. In order to address and mitigate this risk, the 
STEP-YA intervention provides information about anticipating and planning management 
strategies to cope with increased symptoms of fatigue that may occur. In particular, instructions 
will be provided to maintain personal safety by avoiding driving at times when participants are 
likely to become sleepy, and taking appropriate steps if they become sleepy while driving. 
Specifically, participants are instructed that they should immediately pull over to a safe area, stop 
driving and sleep if they become fatigued while driving. Additionally, participants will be 
provided with the contact information of the PI, Dr. Christopher Recklitis, a licensed 
psychologist with extensive clinical experience with cancer survivors and insomnia treatment.  
Participants who have any concerns about the study are encouraged to contact him for assistance.  
Privacy and Confidentiality 
We have taken steps to protect the privacy of participants during all aspects of intervention 
delivery and data collection. 

14 
 
The Zoom videoconferencing technology which will be used to conduct eligibility screening 
conversations and deliver the online intervention is fully HIPAA compliant. The platform is 
licensed to our cancer center, and is currently used for telehealth visits, research visits, 
educational webinars, and study meetings. As of June 2020, Zoom is encrypted using AES 256-
bit GCM encryption standard, the strongest and most robust encryption standard that is currently 
commercially available. For additional security, our institution has locked the password function 
so that passwords are required for all Zoom meetings. A new individual password is created for 
each session, which is then embedded into the link sent to the participant.  This enables the 
participant to access the session securely without having to enter a password, while ensuring that 
only the participant has access to the meeting.  Once the participant enters the meeting, the 
meeting will be locked which provides further protection against any other person entering the 
meeting either accidentally or intentionally.  
The Qualtrics web-based survey platform that will be used to collect study data remotely has 
been used successfully by Dr. Recklitis for other online intervention studies, including a recently 
completed study for young adult cancer survivors (DFCI protocol 17-515).  The Qualtrics 
platform is available through the Harvard Medical School which provides access to a licensed 
version to all HMS faculty and staff as well as affiliated institutions.  Qualtrics is the leading 
global provider of data collection and analysis for academic research, serving over 5,000 
customers in 75 countries. The Qualtrics platform can deliver web and mobile surveys, embed 
videos in a larger survey, send email and mobile reminders, and automate the data collection 
procedures. Qualtrics provides secure collection of survey data using encrypted data transfer and 
complies with HIPAA protections for privacy of patient information. In our application for this 
study, the Qualtrics program will identify participants only by study ID, and will contain no 
identifiers.  Participants will access the Qualtrics platform through a unique link connected only 
to their study ID, and email addresses will not be stored in Qualtrics, so that no protected health 
information is stored on the Qualtrics platform. 
We will use standard IRB-approved and HIPAA compliant measures to maintain patient 
confidentiality, privacy and data security. Data privacy and security procedures will include: a) 
training staff on data sensitivity and protocols for safeguarding confidentiality; b) storing and 
processing sensitive hardcopy in a secured, centralized location; c) securing sensitive hardcopy 
in locked files when not in use; d) removing names, addresses, and other direct identifiers from 

15 
 
hardcopy and computer readable data after they are not necessary for patient tracking and then 
using encrypted codes for subsequent identification of subjects; e) destroying all identifiable 
linkages to data after data accuracy has been verified and final analyses have been completed; f) 
using restricted logon identification and password protection computer protocols for all 
computerized entry, retrieval, and analysis. 
 
7.0 
STATISTICAL ANALYSIS 
Primary Aims:  
1. To test the hypothesis that STEP-YA improves insomnia symptoms (primary outcome) 
and mood (secondary outcome) in young adult cancer survivors. 
2. To determine if improvement in these outcomes are superior in the coaching condition 
compared to the non-coaching condition.   This is a randomized 2-arm trial evaluating the 
STEP-YA intervention when delivered with and without supplementary remote coaching 
session. Immediately after completing baseline assessment subjects will be randomized (1:1 by 
the Sealed Envelope system) to receive the STEP-YA intervention either, 1) alone (Non-
Coaching condition), or 2) with the addition of 2 remote coaching sessions delivered in the two 
weeks following the intervention session. (Coaching condition). Randomization, with block size 
of 4, will be stratified by age category (20-29 years vs. 30-39 years). Primary endpoint is change 
in Insomnia Severity Index score from baseline to 8-weeks post-intervention. Secondary 
endpoint is change in mood symptoms on the Profile of Mood States-Short Form from baseline 
to 8-weeks post-intervention. Primary and secondary endpoints are change at 8 weeks; data 
collected at 4-week post-assessment will be analyzed using similar methods for descriptive and 
exploratory purposes.  
Data analysis for this study will follow methods used for our recently completed clinical trial of 
in-person insomnia interventions delivered to cancer survivors (1R03CA201459). Change scores 
will be treated as continuous variables and primary analyses will compare the arms using 2-way 
analysis of variance with one between-subjects factor (Coaching vs. Non-Coaching) and one 
within-subjects factor (time). Cohen’s d will be used to quantify within-group effect sizes and 
Hedges’ g adjustment will estimate between-group effect sizes. Aim 1 will be addressed using a 

16 
 
within-subjects analysis including all participants to determine if the STEP-YA intervention is 
associated with significant changes in outcome measures over time. Aim 2 will be addressed 
with an analysis that includes both the within – and between-subjects factors as well as an 
interaction term to determine if the effect of the intervention differs between Coaching and non-
Coaching groups (i.e. significant interaction term).  
Sample Size/Power: To meet our aims we require 64 participants with evaluable data but will 
enroll 74 as a hedge against attrition. Our prior single-session educational interventions have 
demonstrated large effects of d ≥ 1.00; the study is conservatively powered to detect an effect 
size of .52 (Primary Aim). With sample size of 64 (32 per arm), the study will have 80% power 
to detect an effect of this size within each arm (α=0.05). To compare the relative improvement in 
the primary endpoint between arms, N=64 subjects will have 80% power  to detect a difference 
of d=0.62 between arms (α=0.05, one-sided).  
Secondary Aim: Explore participant variables associated with clinically significant response to 
the STEP-YA intervention. Logistic regression will be used to identify demographic and sleep 
factors (e.g., age, severity of insomnia symptoms) associated with a reduction of ISI scores ≥ 6 
points at 8 weeks. Variables identified in univariate analysis (p<.10) will be entered into a 
multivariable model estimating STEP-YA response from baseline variables. Analyses will 
explore these relationships separately in the two study arms; Pooled analyses including 
participants across arms will be conducted if univariate analyses indicate relationship of 
predictors and outcome are consistent. 
Missing Data: Participants will be randomized after completing a baseline so complete baseline 
data are assured. Primary analysis will be an intent-to-treat analysis of randomized subjects.  
Based on experience using similar data collection methods, we anticipate minimal missing data 
(<10%). If needed, we will use multiple imputation to account for missing data. Potential factors 
in the imputation model include baseline sleep and mood variables. Sensitivity analysis will be 
used to evaluate the potential impact of imputation on results.   

17 
 
8.0 REFERENCES 
1. Clinton-McHarg T, Carey M, Sanson-Fisher R, Shakeshaft A, Rainbird K. Measuring the 
psychosocial health of adolescent and young adult (AYA) cancer survivors: a critical review. Health 
and quality of life outcomes. 2010;8:25. Epub 2010/03/09. doi: 10.1186/1477-7525-8-25. PubMed 
PMID: 20205922; PMCID: PMC2850329. 
2. Sammarco A. Psychosocial stages and quality of life of women with breast cancer. Cancer Nurs. 
2001;24(4):272-7. Epub 2001/08/15. PubMed PMID: 11502035. 
3. Bleyer A. Young adult oncology: the patients and their survival challenges. CA Cancer J Clin. 
2007;57(4):242-55. Epub 2007/07/13. PubMed PMID: 17626120. 
4. Evan EE, Kaufman M, Cook AB, Zeltzer LK. Sexual health and self-esteem in adolescents and young 
adults with cancer. Cancer. 2006;107(7 Suppl):1672-9. Epub 2006/08/15. doi: 10.1002/cncr.22101. 
PubMed PMID: 16906508. 
5. Mulrooney DA, Ness KK, Neglia JP, Whitton JA, Green DM, Zeltzer LK, Robison LL, Mertens AC. 
Fatigue and sleep disturbance in adult survivors of childhood cancer: a report from the childhood 
cancer survivor study (CCSS). Sleep. 2008;31(2):271-81. Epub 2008/02/16. PubMed PMID: 
18274275; PMCID: 2225565. 
6. Zhou ES, Recklitis CJ. Insomnia in adult survivors of childhood cancer: a report from project 
REACH. Support Care Cancer. 2014;22(11):3061-9. Epub 2014/06/18. doi: 10.1007/s00520-014-
2316-y. PubMed PMID: 24935649. 
7. Zhou ES, Manley PE, Marcus KJ, Recklitis CJ. Medical and Psychosocial Correlates of Insomnia 
Symptoms in Adult Survivors of Pediatric Brain Tumors. J Pediatr Psychol. 2016;41(6):623-30. doi: 
10.1093/jpepsy/jsv071. PubMed PMID: 26275977; PMCID: 26275977. 
8. Sodergren SC, Husson O, Robinson J, Rohde GE, Tomaszewska IM, Vivat B, Dyar R, Darlington 
AS. Systematic review of the health-related quality of life issues facing adolescents and young adults 
with cancer. Qual Life Res. 2017;26(7):1659-72. Epub 2017/03/03. doi: 10.1007/s11136-017-1520-x. 
PubMed PMID: 28251543; PMCID: PMC5486886. 
9. Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin 
Oncol. 2001;19(3):895-908. Epub 2001/02/07. PubMed PMID: 11157043. 
10. Roberts RE, Lee E, Hemandez M, Solari AC. Symptoms of insomnia among adolescents in the lower 
Rio Grande Valley of Texas. Sleep. 2004;27(4):751-60. 
11. Institute of Medicine Committee on Sleep Medicine and Research. Sleep Disorders and Sleep 
Deprivation: An Unmet Public Health Problem. Colten HR, Altevogt BM, editors. Washington (DC): 
National Academies Press (US) 
2006. 
12. Walsh JK, Üstün TB. Prevalence and health consequences of insomnia. Sleep. 1999;22(Suppl, 
3):S427-S36. 
13. Kaneita Y, Ohida T, Uchiyama M, Takemura S, Kawahara K, Yokoyama E, Miyake T, Harano S, 
Suzuki K, Fujita T. The relationship between depression and sleep disturbances: a Japanese 
nationwide general population survey. J Clin Psychiatry. 2006;67(2):196-203. Epub 2006/03/29. 
PubMed PMID: 16566613. 
14. Thase ME. Correlates and consequences of chronic insomnia. Gen Hosp Psychiatry. 2005;27(2):100-
12. doi: 10.1016/j.genhosppsych.2004.09.006. PubMed PMID: 15763121. 
15. Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in 
patients with chronic illness. The Journal of family practice. 2002;51(3):229-35. PubMed PMID: 
11978233. 

18 
 
16. Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry. 2004;65 Suppl 8:13-
9. Epub 2004/05/22. PubMed PMID: 15153063. 
17. Riedel BW, Lichstein KL. Insomnia and daytime functioning. Sleep medicine reviews. 
2000;4(3):277-98. Epub 2003/01/18. doi: 10.1053/smrv.1999.0074. PubMed PMID: 12531170. 
18. Buysse DJ, Angst J, Gamma A, Ajdacic V, Eich D, Rossler W. Prevalence, course, and comorbidity 
of insomnia and depression in young adults. Sleep. 2008;31(4):473-80. Epub 2008/05/07. PubMed 
PMID: 18457234; PMCID: 2279748. 
19. Breslau N, Roth T, Rosenthal L, Andreski P. Sleep disturbance and psychiatric disorders: A 
longitudinal epidemiological study of young adults. Biol Psychiatry. 1996;39(6):411-8. Epub 
1996/03/15. PubMed PMID: 8679786. 
20. Ohayon MM, Carskadon MA, Guilleminault C, Vitiello MV. Meta-analysis of quantitative sleep 
parameters from childhood to old age in healthy individuals: developing normative sleep values 
across the human lifespan. Sleep. 2004;27(7):1255-73. PubMed PMID: 15586779. 
21. Tai E, Buchanan N, Townsend J, Fairley T, Moore A, Richardson LC. Health status of adolescent and 
young adult cancer survivors. Cancer. 2012;118(19):4884-91. doi: 10.1002/cncr.27445. PubMed 
PMID: 22688896. 
22. Burkart M, Sanford S, Dinner S, Sharp L, Kinahan K. Future health of AYA survivors. Pediatr Blood 
Cancer. 2019;66(2):e27516. Epub 2018/10/27. doi: 10.1002/pbc.27516. PubMed PMID: 30362237. 
23. Signorello C, Fardell J, Wakefield CE, Webber K, Cohn R. The cost of cure: chronic conditions in 
survivors of child, adolscent, and young adult cancers. In: Koczwara B, editor. Cancer and Chronic 
Conditions. Singapore: Springer; 2016. p. 371-430. 
24. Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, 
Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy 
compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 
2008;26(28):4651-8. Epub 2008/07/02. doi: 10.1200/JCO.2007.13.9006. PubMed PMID: 18591549. 
25. Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for 
treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001;285(14):1856-64. 
Epub 2001/04/20. PubMed PMID: 11308399. 
26. Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, Nielsen GH, Nordhus IH. 
Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: 
a randomized controlled trial. JAMA. 2006;295(24):2851-8. Epub 2006/06/29. doi: 
10.1001/jama.295.24.2851. PubMed PMID: 16804151. 
27. Johnson JA, Rash JA, Campbell TS, Savard J, Gehrman PR, Perlis M, Carlson LE, Garland SN. A 
systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for 
insomnia (CBT-I) in cancer survivors. Sleep medicine reviews. 2016;27:20-8. Epub 2015/10/06. doi: 
10.1016/j.smrv.2015.07.001. PubMed PMID: 26434673. 
28. Savard J, Savard M-H. Insomnia and Cancer: Prevalence, Nature, and Nonpharmacologic Treatment. 
Sleep Med Clin. 2013;8(3):373-87. doi: http://dx.doi.org/10.1016/j.jsmc.2013.04.006. 
29. Zhou ES, Partridge AH, Syrjala KL, Michaud AL, Recklitis CJ. Evaluation and treatment of insomnia 
in adult cancer survivorship programs. J Cancer Surviv. 2017;11(1):74-9. Epub 2016/08/09. doi: 
10.1007/s11764-016-0564-1. PubMed PMID: 27495283; PMCID: PMC5865603. 
30. Kraus SS, Rabin LA. Sleep America: managing the crisis of adult chronic insomnia and associated 
conditions. Journal of affective disorders. 2012;138(3):192-212. doi: 10.1016/j.jad.2011.05.014. 
PubMed PMID: 21652083. 
31. Thomas A, Grandner M, Nowakowski S, Nesom G, Corbitt C, Perlis ML. Where are the Behavioral 
Sleep Medicine Providers and Where are They Needed? A Geographic Assessment. Behavioral sleep 

19 
 
medicine. 2016;14(6):687-98. Epub 2016/05/10. doi: 10.1080/15402002.2016.1173551. PubMed 
PMID: 27159249; PMCID: PMC5070478. 
32. Perlis ML, Smith MT, Benson-Jungquist C, Posner DA. Cognitive behavioral treatment of insomnia: 
A session-by-session guide. New York, NY: Springer New York; 2005. 
33. Ong JC, Kuo TF, Manber R. Who is at risk for dropout from group cognitive-behavior therapy for 
insomnia? Journal of psychosomatic research. 2008;64(4):419-25. Epub 2008/04/01. doi: 
10.1016/j.jpsychores.2007.10.009. PubMed PMID: 18374742; PMCID: PMC2435302. 
34. Raymond E, Thieblemont C, Alran S, Faivre S. Impact of the COVID-19 Outbreak on the 
Management of Patients with Cancer. Target Oncol. 2020;15(3):249-59. Epub 2020/05/24. doi: 
10.1007/s11523-020-00721-1. PubMed PMID: 32445083; PMCID: PMC7243433. 
35. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in 
primary care. JAMA. 2002;288(19):2469-75. doi: 10.1001/jama.288.19.2469. 
36. Zhou ES, Michaud AL, Recklitis CJ. Developing efficient and effective behavioral treatment for 
insomnia in cancer survivors: Results of a stepped care trial. Cancer. 2020;126(1):165-73. Epub 
2019/09/25. doi: 10.1002/cncr.32509. PubMed PMID: 31550051; PMCID: PMC6906236. 
37. Zhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for 
adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020:e28506. Epub 2020/06/23. 
doi: 10.1002/pbc.28506. PubMed PMID: 32568460. 
38. Zhou ES, Vrooman LM, Manley PE, Crabtree VM, Recklitis CJ. Adapted Delivery of Cognitive-
Behavioral Treatment for Insomnia in Adolescent and Young Adult Cancer Survivors: A Pilot Study. 
Behavioral sleep medicine. 2017;15(4):288-301. Epub 2016/04/15. doi: 
10.1080/15402002.2015.1126597. PubMed PMID: 27077226. 
39. Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for 
insomnia in an adult cancer survivorship program. Psychooncology. 2016. doi: 10.1002/pon.4096. 
40. Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, 
Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT 
model for developing behavioral treatments for chronic diseases. Health Psychol. 2015;34(10):971-
82. Epub 2015/02/03. doi: 10.1037/hea0000161. PubMed PMID: 25642841; PMCID: PMC4522392. 
41. Walker LO, Czajkowski SM. Designing Interventions to Improve the Health of Women Using the 
ORBIT Model. J Obstet Gynecol Neonatal Nurs. 2019;48(2):197-204. Epub 2019/02/23. doi: 
10.1016/j.jogn.2019.02.002. PubMed PMID: 30790528. 
42. Gell NM, Grover KW, Savard L, Dittus K. Outcomes of a text message, Fitbit, and coaching 
intervention on physical activity maintenance among cancer survivors: a randomized control pilot 
trial. J Cancer Surviv. 2020;14(1):80-8. Epub 2019/11/30. doi: 10.1007/s11764-019-00831-4. 
PubMed PMID: 31776849. 
43. Alessi C, Martin JL, Fiorentino L, Fung CH, Dzierzewski JM, Rodriguez Tapia JC, Song Y, 
Josephson K, Jouldjian S, Mitchell MN. Cognitive Behavioral Therapy for Insomnia in Older 
Veterans Using Nonclinician Sleep Coaches: Randomized Controlled Trial. Journal of the American 
Geriatrics Society. 2016;64(9):1830-8. Epub 2016/08/24. doi: 10.1111/jgs.14304. PubMed PMID: 
27550552; PMCID: PMC5351772. 
44. Yun YH, Kim YA, Lee MK, Sim JA, Nam BH, Kim S, Lee ES, Noh DY, Lim JY, Kim S, Kim SY, 
Cho CH, Jung KH, Chun M, Lee SN, Park KH, Park S. A randomized controlled trial of physical 
activity, dietary habit, and distress management with the Leadership and Coaching for Health 
(LEACH) program for disease-free cancer survivors. BMC cancer. 2017;17(1):298. Epub 2017/05/04. 
doi: 10.1186/s12885-017-3290-9. PubMed PMID: 28464804; PMCID: PMC5412037. 
45. Qualtrics. Qualtrics Homepage  [updated 2017; cited 2017 May 30, 2017]. Available from: 
http://qualtrics.com/. 

20 
 
46. Zoom. Zoom for Healthcare: Zoom Video Communications, Inc.;  [cited 2020 2020/6/16]. 
47. Yenikomshian HA, Lerew TL, Tam M, Mandell SP, Honari SE, Pham TN. Evaluation of Burn 
Rounds Using Telemedicine: Perspectives from Patients, Families, and Burn Center Staff. 
Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 
2019;25(1):25-30. Epub 2018/05/08. doi: 10.1089/tmj.2017.0320. PubMed PMID: 29733269. 
48. Brody JE. The doctor will skype you now: How telemedicine could transform the healthcare 
sector2020 2020/6/16. 
49. Garland SN, Johnson JA, Savard J, Gehrman P, Perlis M, Carlson L, Campbell T. Sleeping well with 
cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. 
Neuropsychiatric disease and treatment. 2014;10:1113-24. doi: 10.2147/NDT.S47790. PubMed 
PMID: 24971014; PMCID: 4069142. 
50. Pigeon WR. Treatment of adult insomnia with cognitive-behavioral therapy. J Clin Psychol. 
2010;66(11):1148-60. Epub 2010/09/21. doi: 10.1002/jclp.20737. PubMed PMID: 20853442; 
PMCID: PMC4294319. 
51. Manber R, Friedman, L., Siebern, A. T., Carney, C., Edinger, J., Epstein, D., Haynes, P., Pigeon, W., 
& Karlin, B. E. Cognitive Behavioral Therapy for Insomnia in Veterans: Therapist Manual. 
Washington, DC: U.S. Department of Veteran Affairs; 2014. 
52. Glasgow RE, Davis CL, Funnell MM, Beck A. Implementing practical interventions to support 
chronic illness self-management. Joint Commission journal on quality and safety. 2003;29(11):563-
74. Epub 2003/11/19. PubMed PMID: 14619349. 
53. van Weel-Baumgarten E. Patient-centred information and interventions: tools for lifestyle change? 
Consequences for medical education. Fam Pract. 2008;25 Suppl 1:i67-70. Epub 2008/08/12. doi: 
10.1093/fampra/cmn042. PubMed PMID: 18689857. 
54. Bober SL, Recklitis CJ, Bakan J, Garber JE, Patenaude AF. Addressing sexual dysfunction after risk-
reducing salpingo-oophorectomy: effects of a brief, psychosexual intervention. J Sex Med. 
2015;12(1):189-97. doi: 10.1111/jsm.12713. PubMed PMID: 25311333; PMCID: 4304978. 
55. Reb A, Ruel N, Fakih M, Lai L, Salgia R, Ferrell B, Sampath S, Kim JY, Raz DJ, Sun V. 
Empowering survivors after colorectal and lung cancer treatment: Pilot study of a Self-Management 
Survivorship Care Planning intervention. European journal of oncology nursing : the official journal 
of European Oncology Nursing Society. 2017;29:125-34. Epub 2017/07/20. doi: 
10.1016/j.ejon.2017.06.003. PubMed PMID: 28720259; PMCID: PMC5539921. 
56. Foster C, Fenlon D. Recovery and self-management support following primary cancer treatment. Br J 
Cancer. 2011;105 Suppl 1(Suppl 1):S21-8. Epub 2011/11/09. doi: 10.1038/bjc.2011.419. PubMed 
PMID: 22048029; PMCID: PMC3251956. 
57. Risendal BC, Dwyer A, Seidel RW, Lorig K, Coombs L, Ory MG. Meeting the challenge of cancer 
survivorship in public health: results from the evaluation of the chronic disease self-management 
program for cancer survivors. Front Public Health. 2014;2:214. Epub 2014/01/01. doi: 
10.3389/fpubh.2014.00214. PubMed PMID: 25964922; PMCID: PMC4410485. 
58. McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH. Self-
Management: Enabling and empowering patients living with cancer as a chronic illness. CA Cancer J 
Clin. 2011;61(1):50-62. doi: 10.3322/caac.20093. PubMed PMID: PMC3058905. 
59. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome 
measure for insomnia research. Sleep medicine. 2001;2(4):297-307. Epub 2001/07/05. PubMed 
PMID: 11438246. 
60. Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in 
cancer patients. Psychooncology. 2005;14(6):429-41. doi: 10.1002/pon.860. PubMed PMID: 
15376284. 

21 
 
61. Curran SL, Andrykowski MA, Studts JL. Short Form of the Profile of Mood States (POMS-SF): 
Psychometric information. Psychological Assessment. 1995;7(1):80. 
62. Baker F, Denniston M, Zabora J, Polland A, Dudley WN. A POMS short form for cancer patients: 
psychometric and structural evaluation. Psychooncology. 2002;11(4):273-81. doi: 10.1002/pon.564. 
PubMed PMID: 12203741. 
63. Ware J. SF-36 Health Survey: Manual and Interpretation Guide. Boston, MA: The Health Institute; 
1993. 
64. NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain, Version 2.2021. National 
Comprehensive Cancer Network. 2021. Available from: www.nccn.org. 
65. Adan A, Almirall H. Horne & Ostberg Morningness-Eveningness Questionnaire: A Reduced Scale. 
Person Individ Diff. 1991;12(3):241-53. 
66. Parmanto B, Lewis AN, Jr., Graham KM, Bertolet MH. Development of the Telehealth Usability 
Questionnaire (TUQ). Int J Telerehabil. 2016;8(1):3-10. Epub 2016/08/27. doi: 
10.5195/ijt.2016.6196. PubMed PMID: 27563386; PMCID: PMC4985278.