Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Phase: NA
Conditions: Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia
Sponsor: Dana-Farber Cancer Institute

  
 
 
1 
 
 
 
 
TITLE:  
Insomnia prevention in children with Acute Lymphoblastic Leukemia 
 
 
Sponsor-Investigator: 
National Cancer Institute 1R03CA259894-02 
 
Principal Investigators (PI): 
 
 
Eric Zhou, PhD 
Dana-Farber Cancer Institute 
450 Brookline Avenue 
Boston, MA 02215 
Telephone: 617-632-6162 
Email: eric_zhou@dfci.harvard.edu 
 
 
 
Statistician: 
 
Study Coordinator: 
 
 
Lucille Lokko 
           N/A 
 
 
 
 
Responsible Research Nurse: 
Responsible Data Manager: 
                                  N/A 
 
 
 
 
                                  N/A 
 
 
NCI-Supplied Agent: 
                                                                          N/A 
 
 
VERSION NUMBER: 
1.4 
 
 
VERSION DATE: 
 
November 27, 2023 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
OBJECTIVES ......................................................................................................................4 
1.1 
Study Design ............................................................................................................4 
1.2 
Primary Objectives...................................................................................................4 
2. 
BACKGROUND .................................................................................................................5 
2.1 
Study Disease(s).......................................................................................................5 
3. 
PARTICIPANT SELECTION .............................................................................................5 
3.1 
Eligibility Criteria ....................................................................................................5 
3.2 
Exclusion Criteria ....................................................................................................5 
3.3 
Inclusion of Children and Minorities .......................................................................5 
3.4 
Planned enrollment ..................................................................................................6 
3.5 
Recruitment and consent ..........................................................................................6 
3.6 
Strategies for Retention............................................................................................8 
4. 
REGISTRATION PROCEDURES .....................................................................................8 
4.1 
Registration Process for DF/HCC Institutions .........................................................9 
4.2 
General Guidelines for Other Investigative Sites ....................................................9 
4.3 
Registration Process for Other Investigative Sites...................................................9 
5. 
Study design .........................................................................................................................9 
5.1 
Overall Study Design ...............................................................................................9 
5.2 
Study processes ......................................................................................................10 
5.3 
Agent Administration.............................................................................................12 
5.4 
General Concomitant Medication and Supportive Care Guidelines ......................12 
5.5 
Criteria for Taking a Participant Off Protocol Therapy .........................................12 
5.6 
Duration of Follow Up ...........................................................................................12 
5.7 
Criteria for Taking a Participant Off Study ...........................................................12 
6. 
DOSING DELAYS/DOSE MODIFICATIONS ...............................................................12 
7. 
ADVERSE EVENTS:  LIST AND REPORTING REQUIREMENTS ............................12 
8. 
PHARMACEUTICAL and/or IMAGING AGENT INFORMATION .............................12 
9. 
BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES ........................................12 
10. 
MEASUREMENT OF EFFECT........................................................................................12 
10.1 
Data Safety Monitoring and Data Management ....................................................12 
11. 
STATISTICAL CONSIDERATIONS...............................................................................13 
11.1 
Study Design/Endpoints.........................................................................................13 
11.2 
Sample Size, Accrual Rate and Study Duration ....................................................13 
11.3 
Stratification Factors ..............................................................................................13 

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11.4 
Interim Monitoring Plan ........................................................................................13 
11.5 
Analysis of Primary Endpoints ..............................................................................14 
11.6 
Analysis of Secondary Endpoints .......................... Error! Bookmark not defined. 
12. 
PUBLICATION PLAN .....................................................................................................14 
13. 
Appendices .........................................................................................................................17 
13.1 
Appendix A. Survey measures ...............................................................................18 
13.2 
Appendix B. Sleep Action Plan and Sleep Diary ..................................................22 
13.3 
Appendix C. Oncology nurse navigator script. ......................................................24 
13.4 
Appendix D. Sleep Study Invitation Email/Letter. ................................................25 
13.5 
Appendix E. Recruitment scripts. ..........................................................................26 
 
 
 
 

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1. OBJECTIVES 
 
1.1 
Study Design 
 
Insomnia is a common sequela of pediatric acute lymphoblastic leukemia treatment (ALL), with 
significant health consequences. Prior literature demonstrates that effective methods of dealing 
with medically disrupted sleep include1: (1) parent education (teaching parents about sleep norms 
in children with cancer and setting appropriate expectations)2; (2) extinction (addressing 
problematic sleep onset associations)3; (3) bedtime fading (increasing sleep drive)4; (4) stimulus 
control (leaving the bed if not asleep)4; (5) positive routines (calming activities that cue sleep)5; 
and (6) sleep hygiene (improving sleep environment)6. Despite evidence that preventive 
interventions are effective at reducing insomnia development, this forward-thinking approach 
has not been taken with ALL populations. 
 
We conducted a mixed methods study (DFCI 21-005) of 15 parents of children in active ALL 
maintenance therapy to elicit stakeholder perspectives on optimal sleep interventions to prevent 
insomnia. Parents thematically emphasized that they felt unprepared for the extent of sleep 
disruptions that their child would experience, and how to communicate this with their oncology 
team. Parents voiced a strong desire for more information to learn more about sleep in ALL 
patients, and to be able to access the information from home, without the need for additional 
medical/psychological appointments. 
 
The information collected from these qualitative data, informed the development of a stake-
holder informed program called Sleep ALL Night. The program will be comprised of a sleep 
action plan, coupled with a psychoeducational website that provides families with information 
critical to understanding their child’s sleep, as well as evidence-based strategies to reduce the 
impact of ALL treatment on sleep. 
 
We will conduct a single-arm pilot study to determine the acceptability and feasibility of Sleep 
ALL Night in a cohort of children with ALL receiving maintenance therapy on or as per Dana-
Farber ALL Consortium trials. We are interested in study acceptability both prior to, and 
following the program period, defined as the extent to which people receiving a healthcare 
intervention consider it appropriate based on their anticipated and experiential response to the 
program.7 We are also interested in study feasibility, defined as the practicality of delivering the 
program and conducting clinical research about the program in the setting in which it will be 
implemented in the future. Data from this pilot study will inform a subsequent RCT to evaluate 
efficacy in insomnia prevention among this highly vulnerable patient population.  
 
1.2 
Primary Objectives 
 
1. To evaluate the acceptability and feasibility of the Sleep ALL Night intervention in a 
single arm pilot study of N=30 pediatric patients with ALL. 
a. Acceptability will be defined as (1) ≥30% of eligible participants who are 
approached agree to participate, and (2) participants report an average score ≥4 
(“Agree”) on the Acceptability of Intervention Measure scale.8 
b. Feasibility will be defined as: (1) ≥70% of participants report reviewing the study 

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action plan, (2) ≥50% of participants report accessing the psychoeducational 
website, and (3) ≥80% of participants complete the Intervention Assessment. 
2. To refine the program materials based on participant feedback.  
3. To collect preliminary data assessing the impact of the program on increasing frequency 
of sleep health conversations during Jimmy Fund Clinic medical appointments based on 
electronic medical record review of clinic notes and parent survey response. 
 
2. BACKGROUND 
 
2.1 
Study Disease(s) 
Pediatric acute lymphoblastic leukemia (ALL). 
 
3. PARTICIPANT SELECTION 
 
Children with a diagnosis of de novo ALL receiving treatment in the Maintenance phase of 
therapy either on or as per DFCI 16-001 will serve as the population for study recruitment.  
Selection of participants from this cohort will ensure standardized chemotherapy exposures and 
medical management by their oncology team. We will recruit across low-risk, high-risk and very 
high-risk groups as dexamethasone (a chemotherapy known to impact sleep) dosing on or as per 
DFCI 16-001 is identical across risk groups in the maintenance phase of therapy (6 mg/m2 BID 
administered in 5-day pulses at the start of each 3-week chemotherapy cycle). Given known 
disparities in disordered sleep due to low socioeconomic status and its associated adverse social 
determinants of health, we will utilize available data from the open sociodemographic banking 
protocol DFCI 19-796 and from DFCI 16-001 embedded HMH study to ensure appropriate 
representation of children from low socioeconomic status homes. Annually, ~50 children are 
diagnosed with de novo ALL at DFCI, of whom 30% live in low-SES households, and we plan 
to recruit a population representative of these local data. Patients in the maintenance phase of 
therapy will be recruited for study participation as per the below outlined eligibility criteria. 
 
3.1 
Eligibility Criteria  
 
Eligibility will be determined as follows: 
1. Patient in the Maintenance Phase of therapy on or as per DFCI 16-001 and has completed 
at least two cycles of maintenance therapy to allow adequate recovery from the more 
intensive Consolidation phase.  
2. English or Spanish speaking child and primary caregiver (parent/guardian). 
3. Child aged 4-12 years. 
 
3.2 
Exclusion Criteria 
1. Primary team declines permission to approach.  
2. Children with critical illness (defined as ICU admission)  
 
3.3 
Inclusion of Children and Minorities 
 
Both male and female children of all races and ethnic groups are eligible for this study. This 
study focuses on children with ALL with their parents as survey informants. Surveys are 

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available in both English and Spanish. This study will enroll racial and ethnic minorities in a 
manner that is reflective of the proportion of racial and ethnic minorities diagnosed with 
childhood ALL at DFCI. This study does not focus on any race, ethnicity, or sex. No potential 
research subjects will be excluded from enrollment based on race, ethnic origin, or sex; nor will 
any race, ethnicity or sex be preferentially enrolled. All children and their families receiving 
chemotherapy on or as per DFCI 16-001 who meet the inclusion criteria will be considered 
eligible for participation. 
 
3.4 
Planned enrollment 
 
The overall study will enroll a total of 30 pediatric patients with ALL being treated on or as per 
DFCI 16-001 over 1-year. Eligible families will be offered an opportunity to consent/assent to 
enrollment by experienced research assistants in the hospital or clinic following permission from 
the primary oncology team. This strategy removes recruitment burden from busy clinical staff 
and has been successfully implemented in prior insomnia treatment research conducted by MPI 
Dr. Zhou9. We will recruit a patient sample representative of the racial, ethnic, and 
socioeconomic diversity of our patient population to ensure data from this study are 
generalizable. This will be operationalized by utilizing parent-reported sociodemographic data  
from the currently open sociodemographic banking protocol DFCI 19-796 and from the DFCI 
16-001 embedded HMH study as part of our screening processes.  Should COVID-19 restrictions 
limit in-person clinic visits during the funding period, we will implement a remote recruitment 
and consent strategy involving phone calls/emails after medical appointments in our center 
successful in previous studies by MPI Dr. Zhou (NCT #03613519). 
 
3.5 
Recruitment and consent 
 
Patients being treated on or as per DFCI 16-001 in the maintenance phase of chemotherapy who 
meet the above specified inclusion criteria will be identified via DFCI 16-001 study database and 
the Heme Malignancy clinical tracking system, which is reviewed monthly. Sociodemographic 
data from 16-001 and 19-796 will be used to monitor representativeness of enrolling cohort by 
race, ethnicity, and socioeconomic status to ensure a representative sample.   
 
This study will follow procedures currently in place for other protocols at DFCI (e.g., 17-515, 
17-402) in order to identify potentially eligible participants for recruitment purposes. These 
procedures have been developed in consultation with multiple disease centers and have proven to 
be effective and non-burdensome for clinicians and patients.  Study investigators will collaborate 
with clinicians in the Jimmy Fund Clinic at Dana-Farber Cancer Institute in order to identify and 
recruit eligible participants. Recruitment materials and a study information sheet can be found in 
Appendix D, E and F. After getting permission to approach the subject from their oncology 
provider, subjects will be approached, screened for eligibility, and recruited by a member of the 
study staff. This may occur in-person during a hospitalization or at a scheduled clinic visit, or 
alternatively, via telephone, videoconference, email, or mail, as some medical visits are currently 
conducted as telehealth visits. These “remote” potential participants will receive the Study 
Information Sheet by email or mail. 
 

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Informed Consent: We are requesting a Waiver of Documentation of Informed Consent for this 
pilot study, as it is a minimal risk study involving procedures common in routine clinical and 
non-clinical practice for which signed consent is generally not required outside of the research 
context. All elements of informed consent will be provided verbally prior to study enrollment by 
study staff utilizing the Study Information Sheet (Verbal Informed Consent)) and will be 
provided to families.  
 
Recruitment and Consent methods will include both in-person and remote options:  
 
In-person:  
Following provider permission to approach, eligible parents/guardians will be approached by the 
study staff while in clinic at DFCI or inpatient at BCH and offered an opportunity to participate 
following verbal informed consent. Study staff will offer discussion in a private setting (e.g., 
consult room) and explain details of the study including all elements of informed consent 
including study procedures, study risks and benefits and study goals and methods. The voluntary 
nature of participation will be highlighted. If, after being introduced to the study and having had 
the opportunity to ask questions, parent/guardians are willing to participate, they will be asked to 
verbally communicate their intent to participate which will be documented by study staff. 
Participants ages 10-12 years will provide verbal assent with the parent/guardian present, and the 
parent/guardian will provide verbal consent on the child’s behalf. Records of all instances of 
verbal consent/assent, including date, will be stored in a secure study database managed by the 
study team. Parent/guardians will be provided with a copy of the Sleep Study Information Sheet 
for their reference. The patient’s designated Oncology Nurse Navigator (ONN) will be informed 
of the consent. During the ONN’s visit with the patient and guardian, the family will be provided 
with the sleep action plan and introduced to its use (Appendix C). The sleep action plan will be 
available in both English and Spanish. 
 
Remote: 
In addition to in-person recruitment, study staff may also conduct the consent process remotely. For 
these procedures, email addresses, mailing addresses, and phone numbers will be obtained from the 
patient’s medical record. Eligible participants will be emailed a Sleep Study Invitation (see Appendix 
D) that includes the following:  
• 
An invitation letter, that will explain the purpose and characteristics of the study and an 
opt out message stating they decline to participate at this time 
 
Study staff will then follow up with a phone call after a few days to ensure that the documents have 
been received and gauge the family’s interest in learning more. We will attempt to contact them a 
maximum of three times. No phone messages with the full name Dana-Farber Cancer Institute 
will be used. The phone call will give the parents the opportunity to opt-out or hear additional 
information about the study. 
 
If the family expresses interest in participating, the study staff will provide details on the study, walk 
through the Sleep Study Information Sheet to ensure that all elements of informed consent are 
provided, and offer the family the opportunity to ask questions. If the parent and child (when applicable 
by age) decide to participate, they will provide verbal consent/assent in place of written documentation 
of informed consent. Children ages 10-12 years will provide verbal assent with the parent present, and 

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the parent will provide verbal consent on behalf of the child.  
 
During the patient’s next ONN visit, the family will be provided with the sleep action plan.  
 
We request a waiver of documentation of consent/assent for parents and children based on the 
following considerations: (i) participating in the study constitutes “no more than minimal risk”; (ii) the 
rights and welfare of the subjects will not be adversely affected, since parents and children will be 
given all elements of informed consent both in writing and verbally; (iii) increased study feasibility: we 
would like to minimize the burden that may result from signing a consent form. 
 
3.6 
HIPAA Authorization 
 
A partial HIPAA Waiver of Authorization will be requested to enable thorough screening for 
eligibility. This process involves no more than a minimal risk to subjects’ privacy because 
identifiers will be collected in a secure way and destroyed after the study is closed. In addition, 
the protected health information collected will not be reused or disclosed to any other person or 
entity other than the research team, except as required by law. Because we aim to enroll 
participants within a specific window of maintenance therapy, we have a relatively narrow 
timeframe in which to identify eligible participants. Without such a waiver, we would have to 
rely solely on provider-generated referrals or patient and parent self-referral, which would add an 
undue burden to pediatric hematology/oncology providers and potentially lead to such slow 
participant accrual that the research would be rendered infeasible. Alternatively, requesting 
consent from each potential study participant prior to review of preliminary eligibility would 
result in an unnecessary burden for families. 
 
We will review the participant’s medical records for documentation of any discussion related to 
sleep during routine (non-emergency) JFC clinic appointments for the 12-week period prior to 
and following the ONN baseline visit at study. To obtain permission for the medical record 
abstraction portion of the study, we will have participants provide a signature for HIPAA 
Authorization. As we wish for documented consent to be waived, the HIPAA authorization form 
will be a standalone document. Signed HIPAA authorization will be obtained in person alongside 
the verbal consent. 
 
3.7 
Strategies for Retention 
 
We will actively retain families in this study by utilizing ongoing study team contact to maintain 
engagement as well as modest remuneration for participation. Families enrolled will receive 
small remuneration to off-set the cost of their time participating in the baseline and intervention 
assessment ($20 gift-card at baseline and a $40 gift-card for the intervention assessment). Due to 
the relatively low-participant burden, modest remuneration, and patient-centered nature of the 
intervention we do not anticipate problems with recruitment and retention. 
 
 
4. REGISTRATION PROCEDURES 
 

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4.1 
Registration Process for DF/HCC Institutions 
 
A member of the study team will confirm eligibility criteria and complete the protocol-specific 
eligibility checklist. Institutions will register eligible participants in the Clinical Trials 
Management System (CTMS) OnCore as required by DF/HCC Policy REGIST-101. 
 
4.2 
General Guidelines for Other Investigative Sites 
N/A. 
 
4.3 
Registration Process for Other Investigative Sites 
N/A. 
 
 
5. STUDY DESIGN 
 
5.1 
Overall Study Design 
 
We will conduct a single arm, pilot acceptability and feasibility study of the sleep intervention 
(Sleep ALL Night). 
 
Intervention Structure: As pediatric cancer services are centralized, travel burden for clinical 
care is a treatment barrier.10 It is important that the program content be accessible for those who 
do not live near an academic medical center. While this does not address all family-level 
obstacles to accessing sleep care, this is a vital first step. Further, we recognize that parents of 
pediatric cancer patients are overwhelmed and exhausted from the many medical appointments 
their child has had during treatment11,12 As adherence to multi-session sleep interventions is poor 
in pediatric oncology13 and we have previously demonstrated that a brief psychoeducational 
program is efficacious14 we plan to implement a sleep action plan tool, in conjunction with an 
interactive psychoeducational website. Enrollment in the intervention will take place at the initial 
visit with the ONN and will be followed by the Intervention Survey (administered at Week-3) 
and the overall website monitoring that will occur from Week 1 up until Week 12 (end of study).  
 
The sleep action plan will be presented on a single page (Appendix B), resembling action plans 
that are commonly implemented for children with other chronic medical conditions (e.g., 
asthma).15 The action plan is separated into three ‘zones’: 1) a green zone, indicating that the 
child is sleeping well, reminding families that sleep is something to monitor; 2) a yellow zone, 
indicating that the child’s sleep is worsening, encouraging families to begin tracking their child’s 
sleep; and 3) a red zone, indicating that the child’s sleep is problematic, providing concrete steps 
to take in order to initiate further evaluation and any necessary treatment(s). 
 
ONNs will introduce families to the sleep action plan immediately after study enrollment. 
Spanish interpreters will aid ONNs in explaining the sleep action plan to Spanish speaking 
caregivers. If this is not a feasible time to meet with the families, (i.e., someone has to leave right 
after enrollment), the study team will coordinate a time for the family meet with the ONN at the 
time of their next in person visit. ONNs will explain that if they are interested in further 
information regarding their child’s sleep, that they should review the intervention website. On 

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the website, families will be provided with comprehensive information on how to successfully 
navigate the many potential disruptors of their child’s sleep as they complete maintenance 
therapy. Feedback will be solicited through an Intervention survey (administered at Week-3) 
focused on the acceptability and feasibility of the intervention materials and delivery format for a 
family of a child with cancer. These materials are based on the American Academy of Sleep 
Medicine’s clinical guidelines for managing disordered sleep, and child and family feedback that 
was provided during Phase 1 of this project. Data collection will occur over 3 months via the 
intervention website and during the intervention survey (administered at Week-3). To maximize 
data collection, families will preferably complete the intervention survey (administered at Week-
3) in-person via REDCap or paper/pencil. However, surveys may also be completed using 
alternative methods, including, but not limited to, REDCap link texted/emailed to participants 
and phone/Zoom administration (read aloud by site personnel with answers recorded). 
Reminders to complete the survey will be sent as needed via various methods, including, but not 
limited to, emails, phone calls, and text messages. An Amazon gift card will also be sent to 
families as modest remuneration for their time completing the survey. 
 
5.2 
Study processes 
 
Study procedures are designed to accommodate both in-person, fully remote, or hybrid 
approaches to consent, orientation, study conduct and data collection. 
 
Screening for eligibility: Prior to approach for consent, eligible patients (see Inclusion Criteria) 
will be identified from existing DFCI 16-001 study databases and the Heme Malignancy clinical 
tracking system.  
 
 
 
 
 
 
 
 
 
In Person or 
Remote Eligibility 
Screening
Eligible
Week 0
Baseline Visit
ONN Action Plan Orientation
Baseline Assessment
Baseline Medical Record Abstraction 
Ineligible
 
 
Week 1 – 12 
Website Monitoring 
Week 3 
Intervention survey 
(administered at 
Week-3) 

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Data Collection:  
 
All self-reported outcomes will be collected by parent-report. 
 
Acceptability 
• Study staff: Number of eligible participants who are approached who agree to participate 
in the study. Not administered to participants 
• Parent-completed survey: Self-report to single-items querying current level of concern 
about their child’s sleep, and their interest in learning more about how to improve their 
child’s sleep, on a 10-point scale. Administered during the Baseline Assessment only. 
• Parent-completed survey: Acceptability of Intervention scale16. Administered during the 
Intervention Assessment only. 
 
Feasibility 
• Parent-completed survey: Self-report of frequency of reviewing the study action plan. 
Administered during the Intervention Assessment only. 
• Parent-completed survey: Self-report of frequency of reviewing the study website. 
Administered during the  Intervention Assessment only. 
• Study Staff: Website tracking of frequency of access and time of day of access. Not 
administered to participants. 
• Study Staff: Number of enrolled participants who complete the Intervention Assessment. 
Not administered to participants. 
 
Program material feedback 
• Parent-completed survey: Open-ended Intervention survey (administered at Week-3) 
regarding sleep action plan and website. Administered at Intervention Assessment only. 
 
Program impact 
• Parent-completed: Self-efficacy for Sleep scale (SES)17. The SES is a 9-item scale used 
to assess an individual’s sense of self-efficacy with regards to sleep. Our modified 
version will ask parents to rate how confident they feel about helping their child 
accomplish a behavior, such as “lie in bed feeling mentally relaxed” or “Fall asleep at 
night in less than 30 minutes” on a 5-point scale, with higher scores reflecting greater 
self-efficacy relating to sleep. Administered at Baseline (week 0) and Intervention (week 
3) Assessment. 
• Parent-completed Patient-Reported Outcomes Measurement Information System 
(PROMIS) Sleep Disturbance and Sleep-Related Impairment.18 The PROMIS Sleep 
Disturbance and Sleep-Related Impairment scales are a 16-item measure used to assess 
the extent of a child’s poor sleep and the consequences of their poor sleep Administered 
at Baseline (week 0) and Intervention (week 3) Assessment. 
• Parent-completed Sleep Knowledge Scale. This scale is a 10-item scale designed to 
determine the extent of a parent’s knowledge about sleep in children. Administered at 
Baseline (week 0) and Intervention (week 3) Assessment. 
• Study Staff: CRC review of participant’s medical records for documentation of any 
discussion related to sleep during routine (non-emergency) JFC clinic appointments for 
Week 12 
End of Study Medical 
Record Abstraction 

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the 12-week period prior to and following the ONN baseline visit at study enrollment. 
 
5.3 
Agent Administration 
N/A. 
 
5.4 
General Concomitant Medication and Supportive Care Guidelines 
N/A. 
 
5.5 
Criteria for Taking a Participant Off Protocol Therapy 
N/A. 
 
5.6 
Duration of Follow Up 
Participants will be followed for 3-weeks after their initial ONN baseline visit for the 
Intervention survey; and a total of 12 weeks for any website activity.  
 
5.7 
Criteria for Taking a Participant Off Study 
Participants will not be removed from study, unless they express a desire to do so.  
 
6. DOSING DELAYS/DOSE MODIFICATIONS 
N/A. 
 
7. ADVERSE EVENTS:  LIST AND REPORTING REQUIREMENTS  
If families choose to implement behavioral strategies to try and improve their child’s sleep, they 
may encounter brief periods of resistance from their child, as well as a brief period (<2 weeks) of 
further sleep disruption. This can create increased stress for families. However, the strategies 
described in the program materials are all evidence-based strategies that are commonly used in 
pediatric sleep centers to help children improve their sleep in the long-term, recognizing that 
there may be short-term challenges. In addition, there is a theoretical possibility of anxiety or 
emotional distress as a result of reviewing materials that discuss a common side effect of 
maintenance therapy (sleep disturbance). The emotional risk of anxiety as a result of discussing 
this topic is expected to be minimal based on data from prior qualitative research conducted with 
parents of pediatric cancer patients. Specifically, prior work on this topic has revealed that 
parents are often engaged in discussing this subject because they feel as though their experiences 
can help inform care for other parents who are going through the experience of having a child be 
diagnosed with cancer, and do not report significant stress or anxiety as a result of participation. 
 
8. PHARMACEUTICAL AND/OR IMAGING AGENT INFORMATION 
N/A. 
 
9. BIOMARKER, CORRELATIVE, AND SPECIAL STUDIES 
N/A. 
 
10. MEASUREMENT OF EFFECT 
 
10.1 
Data Safety Monitoring and Data Management 
Data Safety Monitoring is not applicable to this acceptability and feasibility pilot study. 

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All information collected for research purposes will be de-identified prior to analysis. Identifying 
information will include data (names, addresses, phone numbers, emails) necessary to identify 
subjects initially to ask for consent as well as to contact for follow-up survey administration if 
necessary, child’s demographic and disease information. The data will be coded, databases 
secured with a password, and contact information and medical record numbers will be kept in a 
separate database accessible only to the study team, which has undergone HIPAA Certification 
and the training mandated by the IRB. Study databases will not contain identifying information, 
and will be linked to identifying information by a unique study ID. A separate password 
protected key file containing the link between identifying information and research data will be 
maintained by the PI behind the DFCI firewall. We have extensive experience in maintaining 
confidentiality utilizing these methods. 
 
All survey data will be stored in institutionally coordinated databases, including 
Research Electronic Data Capture (REDCap) and Excel. REDCap offers a secure web 
application. A tracking log will also be kept as an Excel spreadsheet. These spreadsheets will be 
located on HIPAA-compliant DF/HCC servers. Physical study documents (i.e. paper surveys) 
will be stored in locked cabinets, and will only be identified by study ID. Study data will be 
entered, stored, and managed in a password-protected database structured for this study on a 
secured server. Data will be verified both at point-of-entry and subsequently by a series of range 
checks, logical between-items checks, and outlier checks. 
 
Safety Monitoring: There are no physical risks to this study. While extremely unlikely, any 
serious event (SAE), defined as an adverse event that results in death, is life threatening, results 
in hospitalization, or results in another important medical event, will be reported to the IRB and 
to the study investigators within 24 hours of occurrence. 
 
11. STATISTICAL CONSIDERATIONS 
 
Quantitative data regarding patient and family sociodemographic and disease data; parent survey 
responses regarding sleep self-efficacy and child sleep will be described by summary statistics.  
 
11.1 
Study Design/Endpoints 
 
11.2 
Sample Size, Accrual Rate and Study Duration 
This study is an acceptability and feasibility study, intended to collect data to inform the design 
of a fully powered clinical trial. We intend to achieve a recruitment target of N=30 over a study 
recruitment period of 12-months. This results in an anticipated recruitment rate of approximately 
3 families per month. 
 
11.3 
Stratification Factors 
N/A. 
 
11.4 
Interim Monitoring Plan 
N/A. 

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11.5 
Analysis of Primary Endpoints 
Patient sociodemographic, disease, and treatment characteristics will be analyzed with 
descriptive statistics. 
 
Primary study outcomes of acceptability and feasibility will be assessed based on the 
Implementation Outcomes Framework and best practice metrics for clinical trials.19,20 The study 
will be deemed acceptable if: (1) ≥30% of eligible participants who are approached agree to 
participate, and (2) participants report an average score ≥4 (“Agree”) on the Acceptability of 
Intervention Measure scale. The study will be deemed feasible if: (1) ≥70% of participants report 
reviewing the study action plan, (2) ≥50% of participants report accessing the psychoeducational 
website, and (3) ≥80% of participants complete the Intervention Assessment. 
 
Primary study outcomes (Self-efficacy for Sleep and Patient-Reported Outcomes Measurement 
Information System Sleep Disturbance and Sleep-Related Impairment total scores; proportion of 
routine visits with a discussion of sleep pre/post ONN baseline visit) will be presented 
descriptively. 
 
11.5.1 Evaluation of Toxicity 
 
NA 
 
11.5.2 Evaluation of the Primary Efficacy Endpoint 
 
NA 
 
12. PUBLICATION PLAN 
Findings will be published in a peer-reviewed journal that is focused on the quality-of-life of 
pediatric cancer patients (e.g., Pediatric Blood and Cancer). 
 
 

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Page 15 
REFERENCES 
 
1. 
Morgenthaler TI, Owens J, Alessi C, et al. Practice Parameters for Behavioral Treatment 
of Bedtime Problems and Night Wakings in Infants and Young Children. Sleep. 
2006;29(10):1277-1281. doi:10.1093/SLEEP/29.10.1277 
2. 
Wolfson A, Lacks P, clinical AFJ of consulting and, 1992 undefined. Effects of parent 
training on infant sleeping patterns, parents’ stress, and perceived parental competence. 
psycnet.apa.org. Accessed July 28, 2022. https://psycnet.apa.org/buy/1992-24420-001 
3. 
Rickert V, Pediatrics CJ, 1988 undefined. Reducing nocturnal awakening and crying 
episodes in infants and young children: A comparison between scheduled awakenings and 
systematic ignoring. publications.aap.org. Accessed July 28, 2022. 
https://publications.aap.org/pediatrics/article-abstract/81/2/203/54953 
4. 
Piazza CC, Fisher W. A FADED BEDTIME WITH RESPONSE COST PROTOCOL 
FOR TREATMENT OF MULTIPLE SLEEP PROBLEMS IN CHILDREN. J Appl Behav 
Anal. 1991;24(1):129-140. doi:10.1901/JABA.1991.24-129 
5. 
Adams L, Pediatrics VR, 1989 undefined. Reducing bedtime tantrums: comparison 
between positive routines and graduated extinction. publications.aap.org. Accessed July 
28, 2022. https://publications.aap.org/pediatrics/article-abstract/84/5/756/56324 
6. 
Tan E, Healey D, Gray AR, Galland BC. Sleep hygiene intervention for youth aged 10 to 
18 years with problematic sleep: A before-after pilot study. BMC Pediatr. 2012;12. 
doi:10.1186/1471-2431-12-189 
7. 
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: An 
overview of reviews and development of a theoretical framework. BMC Health Serv Res. 
2017;17(1). doi:10.1186/S12913-017-2031-8 
8. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly 
developed implementation outcome measures. Implementation Science. 2017;12(1):1-12. 
doi:10.1186/S13012-017-0635-3/TABLES/3 
9. 
Zhou ES, Perini DB, 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. Taylor & Francis. 2017;15(4):288-301. 
doi:10.1080/15402002.2015.1126597 
10. 
Payne S, Jarrett N, Jeffs D. The impact of travel on cancer patients’ experiences of 
treatment: A literature review. Eur J Cancer Care (Engl). 2000;9(4):197-203. 
doi:10.1046/J.1365-2354.2000.00225.X 
11. 
… CJVWJ of P, 2008 undefined. Assessment of parental psychological stress in pediatric 
cancer: A review. academic.oup.com. Accessed July 28, 2022. 
https://academic.oup.com/jpepsy/article-abstract/33/7/694/1034373 
12. 
Gerhardt CA, Salley CG, Lehmann V. The Impact of Pediatric Cancer on the Family. 
Pediatric Psychosocial Oncology: Textbook for Multidisciplinary Care. Published online 
2016:143-155. doi:10.1007/978-3-319-21374-3_9 
13. 
Butow PN, Palmer S, Health Q, Goodenough B, Luckett T. Review of adherence-related 
issues in adolescents and young adults with cancer. researchgate.net. Published online 
2010. doi:10.1200/JCO.2009.22.2802 
14. 
Zhou E, Michaud A, Cancer CR, 2020 undefined. Developing efficient and effective 
behavioral treatment for insomnia in cancer survivors: Results of a stepped care trial. 
Wiley Online Library. 2020;126(1):165-173. doi:10.1002/cncr.32509 

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15. 
Kessler KR. Relationship Between the Use of Asthma Action Plans and Asthma 
Exacerbations in Children With Asthma: A Systematic Review. 
http://dx.doi.org/101177/2150129710388415. 2010;2(1):11-21. 
doi:10.1177/2150129710388415 
16. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly 
developed implementation outcome measures. Implementation Science 2017 12:1. 
2017;12(1):1-12. doi:10.1186/S13012-017-0635-3 
17. 
Johnson R. Predictors of sleep quality: Depression, anxiety, and sleep self-efficacy. 
Undergraduate Theses and Capstone Projects. Published online May 1, 2018. Accessed 
October 16, 2022. https://digitalshowcase.lynchburg.edu/utcp/110 
18. 
Forrest CB, Meltzer LJ, Marcus CL, et al. Development and validation of the PROMIS 
Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018;41(6). 
doi:10.1093/SLEEP/ZSY054 
19. 
Meinert C. ClinicalTrials: Design, Conduct and Analysis.; 2012. Accessed July 28, 2022. 
https://books.google.com/books?hl=en&lr=&id=B0oxE5rNHDkC&oi=fnd&pg=PP1&dq=
Meinert+CL.+Clinical+trials:+design,+conduct+and+analysis.+Vol+39:+OUP+USA%3B
+2012.&ots=bm9nlaT_aJ&sig=_2307SlunutAlJAXmls2KuFPDIw 
20. 
Campbell M, Fitzpatrick R, Haines A, Bmj AK, 2000 undefined. Framework for design 
and evaluation of complex interventions to improve health. bmj.com. Accessed July 28, 
2022. https://www.bmj.com/content/321/7262/694.full-text 
  
 
 

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13. APPENDICES 
 
Appendix A: Acceptability of Intervention Measure (AIM), Intervention Appropriateness 
Measure (IAM), PROMIS and Sleep Knowledge Survey, Sleep Self-Efficacy Scale 
Appendix B: Sleep Action Plan and Sleep Diary 
Appendix C: ONN Script 
Appendix D: Sleep Study Invitation Email/Letter 
Appendix E: Recruitment Script 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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13.1 
Appendix A. Survey measures 
Please circle the number that best reflects your current feelings about the 
following statements. 
In the past 7 days… 
 
 
 
Never      Almost     Sometimes   Almost   
 Always 
                                          never 
 
         always 
 
My child had difficulty 
falling asleep 
 
 
 
 
 
 
My child slept through the 
night 
 
 
 
 
 
 
My child had a problem 
with his/her sleep 
 
 
 
 
 
 
My child had trouble 
sleeping 
 
 
 
 
 
 
It took my child a long 
time to fall asleep 
 
 
 
 
 
 
My child worried about 
not being able to fall 
asleep 
 
 
 
 
 
 
My child woke up at night 
and had trouble falling 
back to sleep 
 
 
 
 
 
 
My child tossed and 
turned at night 
 
 
 
 
 
 
In the past 7 days... 
 
 
 
Never       Almost       Sometimes       Almost 
   Always 
                                            never 
 
               always 
 
My child was sleepy 
during the daytime 
 
 
 
 
 

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My child had a hard time 
concentrating because 
he/she was sleepy 
 
 
 
 
 
 
My child had a hard time 
getting things done 
because he/she was 
sleepy 
 
 
 
 
 
 
My child had problems 
during the school day 
because of poor sleep 
 
 
 
 
 
 
My child had trouble 
staying awake during the 
day 
 
 
 
 
 
 
It was hard for my child to 
have fun because he/she 
was sleepy 
 
 
 
 
 
 
My child could not keep 
his/her eyes open during 
the day 
 
 
 
 
 
 
My child was in a bad 
mood because he/she 
was sleepy 
 
 
 
 
 
 
 
 
Sleep Knowledge 
 
Please indicate whether you believe the following statements to be True or False. 
 
 
 
 
 
 
 
 
 
 
 
True 
 
False 
 
Children who do not get enough sleep are more likely to be 
underweight than overweight. 
 
 
 
Snoring indicates a child is sleeping well. 
 
 
 
Being under- or overactive can be warning signs that  a child is 
not getting enough sleep. 
 
 
 

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Watching TV in the bedroom makes it more difficult for children to 
fall asleep. 
 
 
 
Children should have the same bedtime and wake time on the 
weekdays and weekends. 
 
 
 
Children only need a bedtime routine if they are having trouble 
falling asleep. 
 
 
 
Well-rested children do not need an alarm clock to wake up in the 
morning. 
 
 
 
The average school-aged child needs 1 nap per day. 
 
 
Being overweight can increase a child’s risk of sleep problems. 
 
 
 
The average school-aged child needs ~8 hours of sleep/24 
hours. 
 
 
 
 
 
Sleep Self-Efficacy Scale 
 
For the following 9 items, please rate (by circling a number from 1 to 5) your ability to help your 
child carry out each behavior. If you feel able to accomplish a behavior some of the time but not 
always, you should indicate a lower level of confidence. 
 
Indicate how confident you are that you can help your child: 
 
1. Lie in bed, feeling physically relaxed.  
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
2. Lie in bed, feeling mentally relaxed. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
3. Lie in bed with their thoughts “turned off”. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
4. Fall asleep at night in under 30 minutes. 
 
1 
2 
3 
4 
5 

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Not confident 
 
 
 
Very confident 
 
5. Wake up at night fewer than 3 times. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
6. Go back to sleep withing 15 minutes of waking in the night. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
7. Feel refreshed upon waking in the morning. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
8. Wake after a poor night’s sleep without feeling upset about it. 
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 
9. Not allow poor night’s sleep to interfere with their daily activities.  
 
1 
2 
3 
4 
5 
Not confident 
 
 
 
Very confident 
 

  
 
 
22 
 
 
 
13.2 
Appendix B. Sleep Action Plan and Sleep Diary
 
 
 
sleepallnightDFCI.org 

 
 
 
Page 23 
 
Please use this sleep diary track your child’s sleep. 
 
1. Mark when your child gets into bed at night with a down arrow: ↓ 
2. Shade in periods when child is asleep (including naps):  
3. Mark when your child gets out of bed in the morning with an up arrow: ↑ 
The online sleep diary calculator can provide you with more information about their sleep averages: sleepallnightDFCI.org 
 
                          midnight                                                                                                                                                   noon 
                      12am   1am   2am    3am    4am    5am    6am   7am   8am   9am  10am  11am  12pm   1pm    2pm   3pm    4pm   5pm   6pm    7pm   8pm   9pm  10pm  11pm 
Day: FRI 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
↓ 
 
 
 
Date: 01/16 
 
Day: SAT 
 
 
 
 
 
 
 
 
 
 
 
 
↑ 
 
 
 
 
 
 
 
 
 
 
  
 
Date: 01/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
 
 
 
 
Sleep Diary 
 

  
 
 
24 
 
 
 
13.3 
Appendix C. Oncology nurse navigator script. 
 
The child’s oncology nurse navigator will provide the parent/guardian with the Sleep Action 
Plan and Sleep Diary (Appendix B). 
 
“Hello. I wanted to chat quickly about sleep for [child’s name]. I am bringing this up because by 
the end of leukemia treatment, about 1 in 3 children will have had a hard time with sleep. Rather 
than waiting until the issues with sleep become a big deal, I’m hoping that we can help families 
learn the warning signs to look for. Do you have any questions?” 
 
*Showing the Sleep Action Plan.* 
 
“This is what we call a “Sleep Action Plan” and is designed to help you think about [child’s 
name] sleep. There are 3 zones. The green zone is when your child is sleeping well, and there 
isn’t anything to worry about. You can see here some suggested guidelines for what good sleep 
typically looks like. *Point to left hand side in green zone* 
On the other end is the red zone. This zone means that your child is struggling, and here are the 
common signs to watch out for when it comes to their poor sleep. *Point to left hand side in red 
zone* 
Where do you think [child’s name] would be right now?” 
 
“We want families to talk with us as soon as they think their child’s sleep is in the yellow zone or 
worse. It doesn’t necessarily mean that anything needs to be done, but it means that now your 
child’s medical team will keep sleep at the top of their mind in case we need to do something 
differently to help them sleep and feel better. Does this make sense?” 
 
“Have you ever used a QR code before? At the bottom right of this Sleep Action Plan, you will 
see one. Point your phone or tablet camera and a link appears. 
*Show how to do on patient’s phone, if available; otherwise show on ONN phone* 
Tap this link and it will take you to our special website. I suggest that you take a look at this 
website in the next few days, even if sleep is going well for your family. It provides a lot of 
really good information about what is normal for a child’s sleep, what issues to look out for, and 
tips and strategies that can help your family deal with any sleep issues.” 
 
*Navigate to Sleep Diary calculator on website. Show physical Sleep Diary.* 
 
“This is a Sleep Diary, which is a tool that may be helpful for your family to use to get a sense of 
how your child is sleeping on average. What you will want to do is follow the instructions on the 
sleep diary to track their sleep for about a week, then enter that information into this online 
calculator, which will give you some key sleep facts that .” 
 
“That’s it! We’re hoping that this can be something you put on your fridge, so that it can remind 
you of what to keep a lookout for when it comes to sleep issues. Do you have any last 
questions?” 
 

 
 
 
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13.4 
Appendix D. Sleep Study Invitation Email/Letter. 
 
Dear <name>, 
 
We are contacting you because you may be eligible to participate in a research study we are 
conducting to better understand how we can help families navigate potential sleep problems for 
children during medical treatment. Your child’s doctor is aware of this study and has agreed for 
his/her patients and their families to be contacted. 
 
Your and/or your child’s participation would include: 
• Completing a brief, baseline survey (about 10 minutes) 
• Talking with an oncology nurse navigator for 5-10 minutes about informational materials 
that are available to help families understand sleep during treatment for acute 
lymphoblastic leukemia 
• Completing a brief intervention survey (about 10 minutes) 
 
To thank you for your time, study participants will receive a $20 gift card after completing the 
baseline survey and a $40 gift card after completing the intervention survey. You may opt out of 
any study activities or withdraw from the study at any time.  
 
If you do not wish to participate, you may opt out by emailing sleepallnight@dfci.harvard.edu or 
calling us at 617-632-6221.  
 
If we do not hear from you, a member of our study team will contact you by phone to provide 
additional details about the study and see if you are willing to participate.  
 
Thank you for your consideration and please let us know if you have any questions about the 
study. 
 
Sincerely, 
 
• Jimmy Fund Clinical Leadership 
• Eric Zhou, PhD and Kira Bona, MD, MPH (PIs) 
• Lucille Lokko  (primary study contact/CRC) 
o Email: sleepallnight@dfci.harvard.edu  
 
 
 

 
 
 
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13.5 
Appendix E. Recruitment scripts. 
 
Phone Call Script (Voice message for no answer) 
“Hello. My name is ______, and I am part of the research study team. I am sorry that we were 
not able to reach you. Please call us back at 617-582-7607 at your earliest convenience. Thank 
you.” 
 
Phone Call Script (Recruitment) 
 
“Hello. My name is ________, and I am part of a research study team at Dana-Farber and Boston 
Children’s Hospital. Would now be an okay time to talk?    
 
Thank you for taking the time to chat with me. Our team is conducting a study to learn more 
about how to reduce the risk of sleep problems during therapy for acute lymphoblastic leukemia. 
We know that about 1 in 3 children will wind up having some difficulty with their sleep during 
ALL treatment. You may have received a letter from us recently. The reason you are eligible for 
this study is because your child is receiving maintenance chemotherapy for ALL on or as per 
Dana-Farber Cancer Institute Protocol 16-001, and they are between the ages of 4 and 12 years. 
The goal of this study is to understand the acceptability and feasibility of the Sleep ALL Night 
intervention to help lower the chances that children will develop sleep problems during ALL 
therapy. 
 
Would you be interested in hearing a little more about the details of this study? 
[If no] Thank you for your time.  We will not contact you about this study again.  
 
[If yes] As you may have noticed in the pre-notice letter, there are three parts to this study. If you 
agree the participate, the first part of the study includes 1) completing a brief baseline survey 
(about 5 minutes); 2) talking with an oncology nurse navigator for 5-10 minutes about 
informational materials that are available to help families understand sleep during treatment for 
acute lymphoblastic leukemia; 3) completing an intervention assessment. As a thanks for your 
time, we will send you a $20 gift card after the baseline survey and a $40 gift card after 
completing the intervention assessment survey. 
 
Do you have any questions about that or does this sound like something you would be interested 
in participating in? 
 
[If no] Thank you for your time.  We will not contact you about this study again.  
 
[If yes] Great. If you do not have any questions right now, I can email you a copy of the study 
information sheet and we arrange a time to go over it to obtain your consent to participate. Please 
note that for this study, we will request your verbal consent, instead of asking that you sign a 
consent form. 
May I have your email address?  
Would you like to go ahead and set up a time to meet? 
 

 
 
 
Page 27 
Thank you for your time today. Please know that you can contact our team via email or over the 
phone if you have any additional questions or concerns. Would you like me to give you the 
contact information?