Sleep Disturbance in Hong Kong Children With Cancer: A Cross-Sectional Study Comparing Healthy Counterparts and Children With Other Chronic Diseases
Conditions: Sleep, Sleep Disturbances in Children, Sleep Disturbances
Sponsor: Chinese University of Hong Kong

Mak Shuk Yan, HKCH WM(Paed) 
      
Sleep Disturbance in Hong Kong Children with Cancer: A Cross-Sectional Study 
Comparing Healthy Counterparts and Children with Other Chronic Diseases 
RESEARCH PROTOCOL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
Content 
Page 
Abstract 
2 
1. Introduction 
2 
1.1 Sleep Disturbances in Children with Cancer 
2 
1.2 Comparison with Healthy Children and Other Chronic Illnesses 
3 
2. Study Objectives 
3 
3. Study Significance 
3 
4. Methods 
3 
4.1 Study Design 
3 
4.2 Data Collection 
4 
4.2.1. The Chinese version of Pittsburgh Sleep Quality Index (PSQI) 
4 
4.2.2. The Chinese version of Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) 
4 
4.3 Key Variables 
5 
4.3.1.  Primary Outcome Variable 
5 
4.3.2.  Secondary Outcome Variable 
5 
4.3.3.  Demographic Variables 
5 
4.4 Expected Outcomes 
5 
4.4.1.  Children with Cancer 
5 
4.4.2.  Children with Other Chronic Illnesses 
5 
4.4.3.  Healthy Children 
6 
5. Study Population 
6 
5.1 Children with Cancer (n=50) 
6 
5.2 Children with Other Chronic Illnesses (n=50) 
6 
5.3 Healthy Children (n=50) 
7 
5.4 Exclusion Criteria 
7 
6. Procedure 
7 
7. Statistical Analysis 
7 
8. Parental Consent and Children’s Assent 
8 
8.1 Parental Consent 
8 
8.2 Children’s Assent 
8 
9. Ethical Approval 
9 
10. Data Handling and Record Keeping 
9 
11. Ethical Considerations 
 
References 
10 
 
 
 
 
 
 

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Sleep Disturbance in Hong Kong Children with Cancer: A Cross-Sectional Study Comparing 
Healthy Counterparts and Children with Other Chronic Diseases 
Version No. and Date: Version 4, 6th June, 2025 
 
Principal Investigator: Mak Shuk Yan, Ward Manager, Department of Paediatrics and Adolescent 
Medicine, Hong Kong Children’s Hospital 
 
Abstract 
Sleep disturbances are prevalent among children with chronic illnesses, yet the specific impact of cancer 
on sleep remains underexplored. This prospective and cross-sectional study aims to evaluate the 
prevalence, severity, and characteristics of sleep disturbances in Chinese children with cancer compared 
to healthy peers and children with other chronic diseases. By leveraging validated sleep assessment tools 
and parental reports, the goal is to identify unique challenges faced by children with cancer. Results 
might influence the design of personalized interventions aimed at enhancing the overall well-being of 
children with cancer. 
 
1. Introduction 
Sleep stands as a fundamental foundation for children’s health as it supports physical state, emotional 
stability, and cognitive performance of children (Baddam & Nasser, 2021). Adequate sleep throughout 
childhood remains vital because it promotes physical development, strengthens immune functions, and 
facilitates memory consolidation (Paruthi et al., 2016). Chronic illness patients show a heightened risk 
of sleep disturbances, particularly cancer children, who experience these disturbances due to a 
combination of psychological and physiological and environmental factors (Lee et al., 2017). 
 
1.1 Sleep Disturbances in Children with Cancer 
Research data shows a high incidence of sleep disturbances affecting children treated for cancer since 
studies demonstrate a wide range from 40% to 80% (Ho et al., 2022; Kaushik et al., 2022; Sheikh et 
al., 2021). Sleep disruptions in children stem from various sources. Physiological side effects of cancer 
like pain along with nausea and fatigue emerge as vital factors that disrupt children during cancer 
treatment (Gedaly-Duff et al., 2006; Zupanec et al., 2017). The sleep issues get worse when cancer 
patients use corticosteroids and chemotherapy drugs since these medications disrupt the body's natural 
sleep-wake pattern (Hinds et al., 2007). External hospital factors amplify the existing sleep 
disturbances in pediatric cancer patients. Medical procedures frequently interrupt pediatric patients in 
hospital beds during nighttime hours, while ambient noise and bright lighting in the setting contribute 
to significant barriers to restful sleep (Perdikaris et al., 2009). The combination of internal factors and 
hospital environment elements prevents pediatric cancer patients from experiencing adequate sleep 
quality. 
 
 

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1.2 Comparison with Healthy Children and Other Chronic Illnesses 
In contrast, healthy children generally experience more consistent and undisturbed sleep accentuates 
how chronic illnesses combined with hospitalization damage children’s sleep quality. Children with 
other chronic illnesses also encounter sleep difficulties yet their reasons for these issues differ from 
those diagnosed with cancer. For instance, the condition of asthma triggers nighttime awakenings 
because of wheezing and coughing, while diabetic patients experience disrupted sleep due to 
fluctuating glucose levels (Adavadkar et al., 2022; Meltzer & Mindell, 2017). These conditions cause 
sleep interference but patients tend to experience less psychological and physical distress from cancer 
which leads to milder overall sleep issues. 
 
2. Study Objectives 
The objectives of this study are threefold:  
1) To assess the prevalence and nature of sleep disturbances in children with cancer.  
2) To compare sleep disturbances in children with cancer to those in healthy children and children with 
other chronic diseases.  
3) To identify potential factors contributing to sleep disturbances in paediatric patients. 
 
3. Study Significance 
This study contributes to the comprehension of pediatric sleep disturbances by carefully evaluating sleep 
disruptions among three groups: children with cancer, children with other chronic illnesses, and healthy 
children. The data generated from this study provides vital information for developing targeted therapies 
specific to population groups with linked sleep disturbance factors. By pinpointing specific contributors, 
such as hospital environment, medication effects, or pain, the research will lay the groundwork for 
targeted interventions. These could include reducing nighttime disruptions, refining pain management, 
or designing sleep-friendly hospital settings. Furthermore, integrating tools like the Chinese version of 
PSQI into routine care could enable early detection and management of sleep issues, mitigating long-
term risks like cognitive and emotional deficits 
 
Beyond oncology, the study’s comparison with children who have other chronic illnesses will reveal 
how different conditions uniquely disrupt sleep, guiding tailored strategies for diverse patient groups. 
The healthy control group will establish a benchmark for normal sleep, highlighting the extent of 
disruption caused by chronic illness and elevating sleep as a priority in pediatric care. 
 
4. Methods 
4.1 Study Design 
A prospective and cross-sectional study will be conducted to examine and compare sleep problems in 
three groups of children: 1) healthy children, 2) children with various chronic illnesses and undergoing 
active treatment, and 3) children with cancer and undergoing active treatment. This research design 
allows for a one-time analysis of sleep characteristics and factors that contribute to disturbances in 

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three pediatric groups. The study aims to reveal distinct sleep disturbance characteristics of each 
examined group to determine how sleep changes relate to cancer and other medical conditions among 
individuals. Such research design allows effective assessment through simultaneous analysis to 
acquire an in-depth overview of sleep health dynamics among all groups. 
 
4.2 Data Collection 
This study will employ objective tools to comprehensively assess sleep disturbances and related 
outcomes across the three groups: children with cancer, children with other chronic illnesses, and 
healthy children. 
 
4.2.1 The Chinese version of Pittsburgh Sleep Quality Index (PSQI) 
The PSQI is a widely validated self-report questionnaire designed to evaluate sleep quality 
and disturbances (Mollayeva et al., 2016). Although originally developed for adults, it has 
been adapted and used effectively in pediatric populations with parental assistance for 
younger children (De La Vega et al., 2015; Tietze et al., 2014). The Chinese version of the 
PSQI, as validated for use in Hong Kong Chinese populations, including childhood cancer 
survivors, retains the same structure as the original PSQI (Ho et al., 2021). The PSQI 
consists of 19 self-rated questions and 5 questions rated by a bed partner or roommate. The 
19 self-rated questions are grouped into 7 component scores: subjective sleep quality, sleep 
latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, 
and daytime dysfunction. Each component is scored from 0 to 3, contributing to a global 
score ranging from 0 to 21. The Chinese version of the PSQI is completed by parents for 
younger children (e.g., aged 6-11) or by children aged 12-18 with parental assistance if 
needed. The PSQI’s multidimensional approach will provide detailed insights into specific 
aspects of sleep disruption, such as prolonged sleep onset or frequent awakenings, 
particularly relevant to hospitalized children with cancer.  
 
4.2.2 The Chinese version of Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) 
The PedsQL is a well-established instrument for assessing health-related quality of life in 
children and adolescents aged 2-18 years (Varni et al., 2005). This study will use the 
Chinese version of PedsQL 4.0 Generic Core Scales, which include 23 items across four 
domains: physical functioning (8 items), emotional functioning (5 items), social functioning 
(5 items), and school functioning (5 items). Responses are scored on a 5-point Likert scale 
(0 = never a problem, 4 = almost always a problem), then transformed to a 0-100 scale, 
where higher scores reflect better health-related quality of life. The PedsQL yields a total 
scale score (average of all 23 items), a physical health summary score (average of the 8 
physical functioning items), and a psychosocial health summary score (average of the 15 
items across emotional, social, and school functioning domains). These scores provide a 
comprehensive assessment of overall quality of life and specific physical and psychosocial 

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health outcomes, enabling exploration of how sleep disturbances correlate with broader 
well-being in children with cancer, other chronic illnesses, and healthy controls. Parent-
proxy reports for younger children and self-reports for older participants, mirroring the 
PSQI administration. The PedsQL 4.0 Generic Core Scale has undergone cross-cultural 
adaptation into Chinese and psychometric validation, rendering it suitable for application in 
clinical settings (Ji et al., 2011; Yeung et al., 2012). The Chinese version of PedsQL will 
serve as a secondary measure to explore how sleep disturbances correlate with broader 
quality-of-life outcomes, such as fatigue-related physical limitations or emotional distress, 
which are particularly pertinent to children with chronic illnesses like cancer. 
 
4.3 Key Variables 
4.3.1 Primary Outcome Variable 
Sleep quality, measured by the global PSQI score, will be the primary endpoint. This 
encompasses the seven component scores (e.g., sleep duration, latency, efficiency), 
providing a holistic assessment of sleep health. A global score >5 will classify participants 
as having poor sleep quality, enabling prevalence comparisons across groups. 
 
4.3.2 Secondary Outcome Variable 
Health-related quality of life, assessed via the PedsQL total score and its domain-specific 
subscales (physical, emotional, social, school), as well as physical health summary score 
and psychosocial health summary score will examine the broader impact of sleep 
disturbances. This will help determine, for example, whether poor sleep in children with 
cancer correlates with reduced emotional or physical functioning compared to other groups. 
 
4.3.3 Demographic Variables 
To control for potential confounding effects on sleep patterns and access to healthcare 
resources, the following demographic and clinical variables will be collected: age (in years), 
gender, socioeconomic status (SES), disease type, disease status, and use of hypnotics 
(yes/no). SES will be assessed through parental education (categorized as primary or below, 
junior secondary, senior secondary, or university/college and above). For children with 
cancer, disease type (e.g., leukemia, lymphoma, brain tumor, bone tumor, or others) and 
disease status (e.g., stage 1-4, recurrence, years since diagnosis, treatment type such as 
chemotherapy, radiotherapy, surgery, immunotherapy, transplant, or combination) will be 
recorded. For children with other chronic illnesses, disease type (e.g., asthma, type 1 
diabetes, chronic kidney disease) will be noted. These factors may influence sleep outcomes, 
e.g., older children may report greater daytime dysfunction, or lower parental education 
level may limit access to supportive care, necessitating adjustment in statistical analyses to 
isolate the effects of chronic illness on sleep quality. 
 

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4.4 Expected Outcomes 
This study anticipates uncovering significant differences in sleep quality between children 
hospitalized with cancer, those with other chronic illnesses, and healthy children. The following 
outcomes are expected: 
 
4.4.1 Children with Cancer 
It is hypothesized that children with cancer will exhibit the most severe sleep disturbances 
among the three groups. Factors such as pain associated with the illness, side effects of 
chemotherapy, and frequent nighttime medical interventions are likely to result in reduced 
sleep duration, prolonged sleep latency, and increased sleep fragmentation. Reported data 
from the PSQI are also expected to place a majority of children with cancer above the 
clinical threshold for poor sleep. 
 
4.4.2 Children with Other Chronic Illnesses 
While children with other chronic illnesses are also expected to experience sleep 
disturbances, these disruptions are likely to be less severe than those observed in children 
with cancer. For example, conditions such as asthma or diabetes may cause episodic sleep 
interruptions (e.g., nocturnal coughing or nighttime glucose monitoring), but they are not 
typically compounded by the environmental and psychological stressors associated with 
hospitalization. A smaller percentage of this group is anticipated to exceed the clinical 
threshold for poor sleep on the PSQI. 
 
4.4.3 Healthy Children 
Healthy children are expected to demonstrate the highest sleep quality among the three 
groups, with results showing near-optimal sleep duration and efficiency. Reported data are 
anticipated to reflect low levels of sleep disturbances, with the majority of children scoring 
below the clinical threshold on the PSQI. These findings will provide a baseline for 
understanding how chronic illnesses and hospitalization affect sleep outcomes. 
 
5. Study Population 
This study will enroll Chinese children aged 6 to 18 years, divided into three distinct groups based on 
their health status: children with cancer, children with other chronic illnesses, and healthy children. A 
total sample size of 150 participants (50 per group) will be targeted to ensure adequate statistical power 
for comparative analyses. Recruitment will occur at Hong Kong Children's Hospital or the cancer and 
chronic illness groups, and healthy children will be recruited from healthy siblings of participants or the 
healthy children of hospital staff with specific inclusion and exclusion criteria applied to each group to 
maintain homogeneity and minimize confounding variables. 
 
 

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5.1 Children with Cancer (n=50) 
Participants in this group will be children with a confirmed cancer diagnosis, such as leukemia, 
lymphoma, or solid tumors, who are currently hospitalized for treatment at the inpatient oncology 
wards of Hong Kong Children's Hospital. Eligible participants must be actively receiving cancer-
directed therapy (e.g., chemotherapy, radiation) during their hospital stay. Inclusion criteria require 
that participants, or their parents or legal guardians as proxies, can provide accurate reports about 
sleep patterns, either through self-assessment or observation, ensuring reliable data collection. This 
group will capture the acute impact of cancer treatment and hospitalization on sleep, a critical focus 
of the study. 
 
5.2 Children with Other Chronic Illnesses (n=50) 
This group will comprise children diagnosed with chronic conditions other than cancer, such as asthma, 
type 1 diabetes, or chronic kidney disease, recruited from the cardiac, nephrology, and mixed wards 
of Hong Kong Children's Hospital. These illnesses are selected for their known potential to disrupt 
sleep—e.g., nocturnal asthma symptoms or glucose instability—while differing in pathophysiology 
from cancer. Participants must be under active management for their condition and currently 
hospitalized, but must not have a history of primary sleep disorders (e.g., narcolepsy, obstructive sleep 
apnea) unrelated to their chronic illness. This criterion ensures that observed sleep disturbances are 
attributable to the chronic condition rather than pre-existing sleep pathology. 
 
5.3 Healthy Children (n=50) 
The healthy control group will be of adequate sample size. These include siblings of pediatric patients 
(both oncology and non-oncology wards), and children of hospital staff (e.g., nurses, administrative 
personnel). Inclusion criteria require no history of chronic illness, psychiatric disorders, or known 
sleep conditions. Parental consent and child assent will be obtained for all participants. 
 
5.4 Exclusion Criteria 
Across all three groups, children will be excluded if they are not Chinese and are in intensive care 
units. Children who exhibit severe cognitive impairments that preclude accurate reporting of sleep 
experiences, either by themselves or their parents or legal guardians, will be excluded. Additionally, 
participants with neurological conditions known to independently affect sleep, such as epilepsy or 
cerebral palsy, will be excluded to avoid confounding the primary relationship between chronic illness 
and sleep disturbances. The use of sedative medications unrelated to the participant’s primary 
condition (e.g., for behavioral management rather than cancer treatment) will also disqualify 
participants, as these could artificially alter sleep patterns and obscure study outcomes. These 
exclusion criteria ensure that sleep disturbances observed are primarily linked to the participants’ 
health status rather than extraneous factors. 
 
 

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6. Procedure 
Participants will be enrolled following informed parental consent and, for children under 18, age-
appropriate assent, as detailed in the ethical approval section. Recruitment will occur at Hong Kong 
Children's Hospital for the cancer and chronic illness groups, while healthy controls will be recruited 
from siblings of sick children or children of hospital staff. Once enrolled, parents or legal guardians and 
participants will receive the demographics, the Chinese version of PSQI and PedsQL surveys in paper 
format, depending on preference, with instructions provided by trained research staff. Completing the 
questionnaires is estimated to take approximately 15-20 minutes. For hospitalized children (the cancer 
and chronic illness groups), surveys will be completed during their inpatient stay to capture real-time 
sleep experiences, and the study team will collect completed questionnaires on the same day. Healthy 
children can return their questionnaires via their parents/legal guardians, one extra visit may be required 
by the parents/legal guardians. 
 
7. Statistical Analysis 
Data will be analyzed using SPSS (version 29), a powerful statistical software package designed for 
clinical research. Descriptive statistics such as means, standard deviations, and frequencies, will 
summarize demographic characteristics (e.g., age, gender distribution), as well as PSQI global and 
component scores, and PedsQL total and subscale scores for each group. To compare sleep quality and 
health-related quality of life across the three groups, a one-way analysis of variance (ANOVA) will be 
used for continuous variables (e.g., PSQI global score, sleep duration, PedsQL physical functioning 
score). For secondary analyses, multiple linear regression will examine the relationships between sleep 
quality (PSQI score) and potential predictors (e.g., type of cancer treatment, pain levels) while adjusting 
for confounding factors such as age, gender, and socioeconomic status (SES). Pearson or Spearman 
correlations will be utilized to assess the relationships between PSQI and PedsQL scores, helping to 
evaluate the impact of sleep disturbances on health-related quality of life. A p-value of less than 0.05 
will indicate statistical significance, and effect sizes (e.g., eta-squared) will be reported to quantify the 
magnitude of differences. 
 
8. Parental Consent and Children’s Assent 
Ensuring the ethical participation of children in this study requires a dual approach, involving obtaining 
informed consent from parents or legal guardians and, where appropriate, obtaining assent from the 
children themselves. 
 
8.1 Parental Consent 
Informed consent will be obtained from the parents or legal guardians of all participants prior to 
enrollment. The consent process will involve a detailed explanation of the study’s purpose – to 
evaluate sleep disturbances across children with cancer, healthy children, and those with other chronic 
diseases –along with its procedures, potential risks, and benefits. Parents or legal guardians will 
receive both verbal and written information in clear, non-technical language, including a description 

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of data collection methods, the voluntary nature of participation, and their right to withdraw their child 
at any time without affecting medical care or services received at Hong Kong Children’s Hospital. 
The consent form will also outline confidentiality measures and the minimal risks involved, such as 
mild emotional distress from discussing sleep issues. Parents or legal guardians will have the 
opportunity to ask questions and will sign the consent form only after indicating full understanding 
and agreement. 
 
8.2 Children’s Assent 
In addition to parental consent, age-appropriate assent will be sought from children aged 6 years and 
older, recognizing their capacity to understand and agree to participate in research. The assent process 
will be tailored to the child’s developmental stage and health condition. For children with cancer or 
other chronic illnesses, who may be more familiar with medical contexts, the explanation will be 
sensitive to their experiences while remaining concise and engaging. Research staff will use simple, 
age-appropriate language to describe what participation involves, including answering questions 
about sleep through their parents/legal guardians or research staff. They will be reassured that there 
are no needles or painful procedures, that they can stop at any time, and that their decision will not 
impact their treatment or care. Assents will be documented via a signature or verbal confirmation, 
depending on the child’s ability and preference, ensuring that their willingness to participate is 
respected. If a child expresses reluctance or distress, even with parental consent, their participation 
will be discontinued to prioritize their well-being. 
 
9. Ethical Approval 
This study will adhere to the highest ethical standards governing research involving human participants, 
particularly vulnerable populations such as children. Prior to commencing data collection, ethical 
approval will be sought from the Hospital Authority Central Institutional Review Board (IRB), ensuring 
that the study design, recruitment procedures, and data handling practices align with regulations and 
ethical guidelines. The IRB review will assess the study’s potential risks and benefits, with a focus on 
minimizing any discomfort or burden to participants, especially given the involvement of children with 
serious illnesses like cancer. Informed consent will be obtained from parents or legal guardians of all 
participants, and age-appropriate assent will be sought from children aged 6 years and older, following 
best practices for pediatric research (Katz et al., 2016). Participants and their families will be fully 
informed about the study’s purpose, procedures, voluntary nature, and their right to withdraw at any time 
without consequence to their medical care. 
 
10. Data Handling and Record Keeping 
Protecting the privacy and confidentiality of participants is a paramount concern in this study. To protect 
patient privacy, all research data would be handled in line with Hospital Authority/Hospital’s policy in 
handling/storage/destruction of patients/ medical records. All data collected including demographic 
information, clinical records, the Chinese version of the PSQI, and the Chinese version of PedsOL 4.0, 

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will be de-identified using unique participant codes rather than names or other identifiable markers. 
These codes will be stored separately from the data in a password-protected electronic file accessible 
only to authorized research personnel. Physical records, such as consent forms, will be kept in a locked 
cabinet within a secure ward manager’s office at Hong Kong Children’s Hospital. Electronic data will 
be stored on an encrypted, institution-approved server compliant for safeguarding protected health 
information. Access to the data will be restricted to the principal investigator and trained research staff 
directly involved in the study, and no identifiable information will be disclosed in publications or 
presentations. Upon study completion, data will be retained for a minimum of five years, after which it 
will be securely destroyed. Paper records shredded, and electronic files permanently deleted to prevent 
unauthorized access. In the event of an incidental finding (e.g., severe untreated sleep apnea), the 
research team will notify the participant’s parents/legal guardian and healthcare provider while 
maintaining confidentiality, ensuring appropriate follow-up care without breaching privacy protocols. 
 
11. Ethical Considerations 
The issue of confidentiality will be solved by recording the data in a manner that does not allow the 
participants to be identified (i.e. using a non-recognizable code for each patient). The study will be 
conducted in compliance with Declaration of Helsinki. 
 
 
 

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