Pediatrics CancerNCT07323069
A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients
A study testing Sleep Hygiene Education, Progressive Muscle Relaxation and Breathing exercises in people with Pediatrics Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Sleep is essential for a child's development, influencing cognitive function, emotional stability, recovery, and overall well-being. Prolonged and intensive treatments for pediatric oncology patients can lead to sleep disturbances that are often overlooked by caregivers and healthcare professionals as temporary side… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatrics Cancer
- What is being tested?
- Sleep Hygiene Education, Progressive Muscle Relaxation and Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who can read and communicate in Chinese
- Aged 6 to 12 years old (school-aged children).
- Diagnosed with cancer and currently undergoing active treatment.
- Identified as experiencing sleep disturbances, defined by a Chinese Pittsburgh Sleep Quality Index (PSQI) global score of ≥5.
Who cannot join
- Diagnosed with hematological diseases unrelated to cancer (e.g., sickle cell anemia, thalassemia).
- Presence of severe cognitive impairment, which may hinder the ability to follow instructions or engage with intervention components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Kowloon Bay
Shuk Yan Mak, +852 62229509, nafertes@gmail.com
Shuk Yan Mak
About this study
Official title: The Dreamcatchers Programme - A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients: A Pilot Randomized Controlled Trial
Sleep is essential for a child's development, influencing cognitive function, emotional stability, recovery, and overall well-being. Prolonged and intensive treatments for pediatric oncology patients can lead to sleep disturbances that are often overlooked by caregivers and healthcare professionals as temporary side effects. Symptoms may include difficulty initiating or maintaining sleep, reduced sleep duration, or perceived poor sleep quality. Recent studies indicate that sleep disturbances affect between 13% to 50% of leukemia survivors and up to 80% of children with central nervous system tumors. A recent study in Hong Kong found that approximately 45% of pediatric oncology survivors continue to face sleep challenges, underscoring the global and local relevance of this issue.
These sleep disturbances in this vulnerable group often result from factors such as pain and nausea due to chemotherapy side effects, which can be exacerbated by corticosteroids. The immediate discomfort caused by sleep disruptions can significantly affect treatment adherence, daily activities, social interactions, and overall quality of life.
Read more
While pharmacological approaches remain the standard treatment for pediatric sleep disturbances, this method carries significant risks, including potential drug interactions and dependence. Non-pharmacological options, however, empower patients and caregivers to manage sleep issues without increasing medication use, promoting a proactive approach to sleep health.
In response to the need to enhance sleep quality among pediatric oncology patients, the Dreamcatchers Programme was developed as a nurse-led initiative. This program focuses on relaxation and offers sustainable strategies for improved sleep through sleep hygiene practices, progressive muscle relaxation (PMR), and breathing exercises for both patients and caregivers. Evidence-based interventions equip nurses with holistic techniques that address gaps in their knowledge and skills.
This project proposal details a randomized controlled pilot study aimed at evaluating the feasibility and preliminary effectiveness of the Dreamcatchers Programme, setting the groundwork for a standardized sleep management protocol in pediatric oncology care.
Read the detailed description
The trial employs a prospective, single-blind, waitlist-controlled design with 1:1 allocation. Block randomization, generated by computer and concealed in sealed opaque envelopes, ensures balanced group sizes and minimizes selection and allocation bias. Blinding of participants and caregivers is infeasible due to the intervention's nature, but outcome assessors (nurses collecting data) remain blinded to group assignment to reduce observer bias.
To prevent contamination, intervention sessions occur in a separate educational room away from clinical areas. Access to supportive QR code videos of relaxation exercises is password-protected and restricted to the intervention group.
Recruitment uses simple random sampling from a computer-generated list of eligible attendees at the ambulatory chemotherapy day center of Hong Kong Children's Hospital (HKCH). Day patients are selected over inpatients for their stable attendance patterns, which support consistent intervention delivery, follow-up, and data collection. This choice enhances feasibility, aligns with the programme's intended home-based application, minimizes hospital-related confounders (e.g., interruptions, equipment), and improves generalizability to outpatient and survivorship settings.
The principal investigator approaches eligible families, obtains informed consent from caregivers, and assent from children where appropriate, reducing selection bias.
Sample size follows methodological guidance emphasizing logistical and feasibility assessments over powered hypothesis testing.
This multi-component, nurse-delivered programme targets sleep hygiene, progressive muscle relaxation (PMR), and breathing exercises.
Initial Group Education Session (~45 minutes, max 10 participants/caregivers): Nurse-facilitated PowerPoint covers sleep's role in recovery, optimal sleep environment (lighting, noise), consistent routines, screen-free alternatives, diaphragmatic breathing/PMR for relaxation, and sleep diary use (booklet for tracking habits, duration, and exercises).
Practical Demonstrations: Hands-on practice of PMR (10-15 minutes; gentle, suitable for reduced mobility/strength) and box breathing (5-10 minutes; pre-bedtime to reduce arousal via vagal stimulation).
Support Materials: QR code access to video recordings of exercises (adapted from established resources).
Weekly Follow-ups (4 weeks): Reinforcement, practice, troubleshooting, and monitoring of adherence/sleep hygiene.
Waitlist participants receive routine hospital support and general pediatric oncology education (e.g., neutropenic diet), maintaining engagement without sleep-specific content.
De-identified data (unique codes) are stored securely (password-protected files, locked physical records) per Hospital Authority policies, retained 5 years post-study, then destroyed. Incidental severe findings prompt notification while maintaining confidentiality.
- Conditions
- Pediatrics Cancer
- Being tested
- Sleep Hygiene Education, Progressive Muscle Relaxation, Breathing exercises
- Keywords
- pediatrics, oncology, leukemia, solid tumour, sleep, sleep quality, quality of life, sleep disturbances
- Medical subject headings
- Neoplasms, Leukemia, Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationOther
The first part of the intervention consists of a group education session on sleep hygiene. Each session will accommodate a maximum of 10 participants and will last approximately 45 minutes facilitated by a nurse using a PowerPoint presentation.
Progressive Muscle RelaxationOther
Following the education session, practical demonstrations of PMR will be conducted, allowing patients and caregivers to practice what they have learned. These exercises will be designed to be simple, age-appropriate, and easily integrated into daily routines.
PMR helps lower stress and anxiety by modulating the activities of the autonomic nervous system. The entire PMR routine will take approximately 10-15 minutes, consistent with the duration of relaxation exercises noted in earlier research.
Breathing exercisesOther
Breathing exercises will also be demonstrated and advised to be used before bedtime, aiming to reduce physiological arousal and promote relaxation through slowing down breathing rate, amplifying vagus nerve activity and normalizing stress responses. The breathing routine, incorporating box breathing techniques, will last 5-10 minutes and is to be practiced as part of the children's wind-down routine before sleep.
| Study group | Role | What they receive |
|---|---|---|
| Education with Exercises | Experimental | The intervention group will receive the Dreamcatchers Programme, including sleep hygiene education, PMR, and breathing control exercises, which will be delivered over 4 weeks with weekly in-person follow-ups. Receives: Other: Sleep Hygiene Education; Other: Progressive Muscle Relaxation; Other: Breathing exercises |
| Control | No intervention | The waitlist control group will continue to receive routine hospital support and pediatric oncology health information (e.g., neutropenic diet tips) to maintain engagement without sleep-specific strategies. In order to ensure fairness, participants of the waitlist control group will be given access to the Dreamcatchers Programme once the final follow-up assessment is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
The primary outcome focuses on improvements in sleep quality among pediatric oncology patients aged 6-12 years, as measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI score is a number from 0-21, with 0 being best and higher scores indicating worse sleep; a score over 5 suggests significant sleep problems.
Measured: 3 months
Secondary outcomes (1)
Overall Quality of Life
The secondary outcome focuses on enhancing the overall quality of life of participating children during active cancer treatment, as measured by the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module 3.0. PedsQL score ranges from 0-100, and higher PedsQL scores indicate better quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pediatrics CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Children's Hospital
- Responsible party
- Principal investigator, Mak Shuk Yan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323069
- Sponsor's protocol ID
- PAED-2025-074
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some participants do not wish to share their information.
Publications
Zupanec S, Jones H, McRae L, Papaconstantinou E, Weston J, Stremler R. A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial. Cancer Nurs. 2017 Nov/Dec;40(6):488-496. doi: 10.1097/NCC.0000000000000457.
PubMed 27922922Zaccaro A, Piarulli A, Laurino M, Garbella E, Menicucci D, Neri B, Gemignani A. How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018.
PubMed 30245619Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13.
PubMed 25679070Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Tanriverdi M, Cakir E, Akkoyunlu ME, Cakir FB. Effect of virtual reality-based exercise intervention on sleep quality in children with acute lymphoblastic leukemia and healthy siblings: A randomized controlled trial. Palliat Support Care. 2022 Aug;20(4):455-461. doi: 10.1017/S1478951522000268.
PubMed 35289266Sriasih NK, Allenidekania, Wanda D. The Effects of the COMMASH-E Intervention on the Fatigue, Sleep Quality and Functional Status of Children with Cancer in Indonesia. Compr Child Adolesc Nurs. 2019;42(sup1):197-207. doi: 10.1080/24694193.2019.1594451.
PubMed 31192716Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53.
PubMed 3332317Sari E, Gundogdu F, Semerci R. The Effect of Progressive Muscle Relaxation Exercises on Sleep Quality in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Study. Semin Oncol Nurs. 2024 Apr;40(2):151620. doi: 10.1016/j.soncn.2024.151620. Epub 2024 Mar 16.
PubMed 38494385Kotian PL, El-Kattan Y, Niwas S, Wu M, Lin TH, Bourdreaux B, Saini SK, Spaulding A, Kellogg-Yelder D, Parker C, Chambers-Wilson R, Bantia S, Miao Z, Williams J, Schmittou A, Raman K, Wiget PA, Chand P, Sudhakar Babu Y. Design, synthesis, and structure-activity relationships of selective biphenyl antithrombotic tissue factor/factor VIIa inhibitors. Eur J Med Chem. 2025 Sep 15;294:117708. doi: 10.1016/j.ejmech.2025.117708. Epub 2025 May 6.
PubMed 40378577Meltzer LJ, Montgomery-Downs HE, Insana SP, Walsh CM. Use of actigraphy for assessment in pediatric sleep research. Sleep Med Rev. 2012 Oct;16(5):463-75. doi: 10.1016/j.smrv.2011.10.002. Epub 2012 Mar 15.
PubMed 22424706Matricciani L, Paquet C, Galland B, Short M, Olds T. Children's sleep and health: A meta-review. Sleep Med Rev. 2019 Aug;46:136-150. doi: 10.1016/j.smrv.2019.04.011. Epub 2019 Apr 23.
PubMed 31121414Li HC, Williams PD, Williams AR, Chung JO, Chiu SY, Lopez V. Confirmatory factor analysis of the Chinese version of the Pediatric Quality-of-Life Inventory Cancer Module. Cancer Nurs. 2013 Nov-Dec;36(6):E66-72. doi: 10.1097/NCC.0b013e318276e056.
PubMed 23348659Lee S, Narendran G, Tomfohr-Madsen L, Schulte F. A systematic review of sleep in hospitalized pediatric cancer patients. Psychooncology. 2017 Aug;26(8):1059-1069. doi: 10.1002/pon.4149. Epub 2016 May 5.
PubMed 27147507da Silva Santa IN, Schveitzer MC, Dos Santos MLBM, Ghelman R, Filho VO. MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102725. doi: 10.1016/j.ctim.2021.102725. Epub 2021 May 5.
PubMed 33964406Cheung YT, Brinkman TM, Mulrooney DA, Mzayek Y, Liu W, Banerjee P, Panoskaltsis-Mortari A, Srivastava D, Pui CH, Robison LL, Hudson MM, Krull KR. Impact of sleep, fatigue, and systemic inflammation on neurocognitive and behavioral outcomes in long-term survivors of childhood acute lymphoblastic leukemia. Cancer. 2017 Sep 1;123(17):3410-3419. doi: 10.1002/cncr.30742. Epub 2017 Apr 27.
PubMed 28452142
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dreamcatchers Programme - A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07323069
- Acronym / sponsor ID
- PAED-2025-074
- Conditions
- Pediatrics Cancer
- Keywords
- pediatrics, oncology, leukemia, solid tumour, sleep, sleep quality, quality of life, sleep disturbances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Children's Hospital
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is essential for a child's development, influencing cognitive function, emotional stability, recovery, and overall well-being. Prolonged and intensive treatments for pediatric oncology patients can lead to sleep disturbances that are often overlooked by caregivers and healthcare professionals as temporary side effects. Symptoms may include difficulty initiating or maintaining sleep, reduced sleep duration, or perceived poor sleep quality. Recent studies indicate that sleep disturbances affect between 13% to 50% of leukemia survivors and up to 80% of children with central nervous system tumors. A recent study in Hong Kong found that approximately 45% of pediatric oncology survivors continue to face sleep challenges, underscoring the global and local relevance of this issue.
These sleep disturbances in this vulnerable group often result from factors such as pain and nausea due to chemotherapy side effects, which can be exacerbated by corticosteroids. The immediate discomfort caused by sleep disruptions can significantly affect treatment adherence, daily activities, social interactions, and overall quality of life.
While pharmacological approaches remain the standard treatment for pediatric sleep disturbances, this method carries significant risks, including potential drug interactions and dependence. Non-pharmacological options, however, empower patients and caregivers to manage sleep issues without increasing medication use, promoting a proactive approach to sleep health.
In response to the need to enhance sleep quality among pediatric oncology patients, the Dreamcatchers Programme was developed as a nurse-led initiative. This program focuses on relaxation and offers sustainable strategies for improved sleep through sleep hygiene practices, progressive muscle relaxation (PMR), and breathing exercises for both patients and caregivers. Evidence-based interventions equip nurses with holistic techniques that address gaps in their knowledge and skills.
This project proposal details a randomized controlled pilot study aimed at evaluating the feasibility and preliminary effectiveness of the Dreamcatchers Programme, setting the groundwork for a standardized sleep management protocol in pediatric oncology care.
Detailed description
The trial employs a prospective, single-blind, waitlist-controlled design with 1:1 allocation. Block randomization, generated by computer and concealed in sealed opaque envelopes, ensures balanced group sizes and minimizes selection and allocation bias. Blinding of participants and caregivers is infeasible due to the intervention's nature, but outcome assessors (nurses collecting data) remain blinded to group assignment to reduce observer bias.
To prevent contamination, intervention sessions occur in a separate educational room away from clinical areas. Access to supportive QR code videos of relaxation exercises is password-protected and restricted to the intervention group.
Recruitment uses simple random sampling from a computer-generated list of eligible attendees at the ambulatory chemotherapy day center of Hong Kong Children's Hospital (HKCH). Day patients are selected over inpatients for their stable attendance patterns, which support consistent intervention delivery, follow-up, and data collection. This choice enhances feasibility, aligns with the programme's intended home-based application, minimizes hospital-related confounders (e.g., interruptions, equipment), and improves generalizability to outpatient and survivorship settings.
The principal investigator approaches eligible families, obtains informed consent from caregivers, and assent from children where appropriate, reducing selection bias.
Sample size follows methodological guidance emphasizing logistical and feasibility assessments over powered hypothesis testing.
This multi-component, nurse-delivered programme targets sleep hygiene, progressive muscle relaxation (PMR), and breathing exercises.
Initial Group Education Session (~45 minutes, max 10 participants/caregivers): Nurse-facilitated PowerPoint covers sleep's role in recovery, optimal sleep environment (lighting, noise), consistent routines, screen-free alternatives, diaphragmatic breathing/PMR for relaxation, and sleep diary use (booklet for tracking habits, duration, and exercises).
Practical Demonstrations: Hands-on practice of PMR (10-15 minutes; gentle, suitable for reduced mobility/strength) and box breathing (5-10 minutes; pre-bedtime to reduce arousal via vagal stimulation).
Support Materials: QR code access to video recordings of exercises (adapted from established resources).
Weekly Follow-ups (4 weeks): Reinforcement, practice, troubleshooting, and monitoring of adherence/sleep hygiene.
Waitlist participants receive routine hospital support and general pediatric oncology education (e.g., neutropenic diet), maintaining engagement without sleep-specific content.
De-identified data (unique codes) are stored securely (password-protected files, locked physical records) per Hospital Authority policies, retained 5 years post-study, then destroyed. Incidental severe findings prompt notification while maintaining confidentiality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education with Exercises | Experimental | Other: Sleep Hygiene Education, Other: Progressive Muscle Relaxation, Other: Breathing exercisesThe intervention group will receive the Dreamcatchers Programme, including sleep hygiene education, PMR, and breathing control exercises, which will be delivered over 4 weeks with weekly in-person follow-ups. |
| Control | No intervention | –The waitlist control group will continue to receive routine hospital support and pediatric oncology health information (e.g., neutropenic diet tips) to maintain engagement without sleep-specific strategies. In order to ensure fairness, participants of the waitlist control group will be given access to the Dreamcatchers Programme once the final follow-up assessment is completed. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who can read and communicate in Chinese
- Aged 6 to 12 years old (school-aged children).
- Diagnosed with cancer and currently undergoing active treatment.
- Identified as experiencing sleep disturbances, defined by a Chinese Pittsburgh Sleep Quality Index (PSQI) global score of ≥5.
Key exclusion criteria (2 listed)
- Diagnosed with hematological diseases unrelated to cancer (e.g., sickle cell anemia, thalassemia).
- Presence of severe cognitive impairment, which may hinder the ability to follow instructions or engage with intervention components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationThe first part of the intervention consists of a group education session on sleep hygiene. Each session will accommodate a maximum of 10 participants and will last approximately 45 minutes facilitated by a nurse using a PowerPoint presentation. | Other | Education with Exercises |
| Progressive Muscle RelaxationFollowing the education session, practical demonstrations of PMR will be conducted, allowing patients and caregivers to practice what they have learned. These exercises will be designed to be simple, age-appropriate, and easily integrated into daily routines. PMR helps lower stress and anxiety by modulating the activities of the autonomic nervous system. The entire PMR routine will take approximately 10-15 minutes, consistent with the duration of relaxation exercises noted in earlier research. | Other | Education with Exercises |
| Breathing exercisesBreathing exercises will also be demonstrated and advised to be used before bedtime, aiming to reduce physiological arousal and promote relaxation through slowing down breathing rate, amplifying vagus nerve activity and normalizing stress responses. The breathing routine, incorporating box breathing techniques, will last 5-10 minutes and is to be practiced as part of the children's wind-down routine before sleep. | Other | Education with Exercises |
Primary outcome
Sleep Quality
Time frame: 3 months
The primary outcome focuses on improvements in sleep quality among pediatric oncology patients aged 6-12 years, as measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI score is a number from 0-21, with 0 being best and higher scores indicating worse sleep; a score over 5 suggests significant sleep problems.
1 secondary outcome
Overall Quality of Life
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 27922922Zupanec S, Jones H, McRae L, Papaconstantinou E, Weston J, Stremler R. A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial. Cancer Nurs. 2017 Nov/Dec;40(6):488-496. doi: 10.1097/NCC.0000000000000457.
- Background: PubMed 30245619Zaccaro A, Piarulli A, Laurino M, Garbella E, Menicucci D, Neri B, Gemignani A. How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018.
- Background: PubMed 25679070Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 35289266Tanriverdi M, Cakir E, Akkoyunlu ME, Cakir FB. Effect of virtual reality-based exercise intervention on sleep quality in children with acute lymphoblastic leukemia and healthy siblings: A randomized controlled trial. Palliat Support Care. 2022 Aug;20(4):455-461. doi: 10.1017/S1478951522000268.
- Background: PubMed 31192716Sriasih NK, Allenidekania, Wanda D. The Effects of the COMMASH-E Intervention on the Fatigue, Sleep Quality and Functional Status of Children with Cancer in Indonesia. Compr Child Adolesc Nurs. 2019;42(sup1):197-207. doi: 10.1080/24694193.2019.1594451.
- Background: PubMed 3332317Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53.
- Background: PubMed 38494385Sari E, Gundogdu F, Semerci R. The Effect of Progressive Muscle Relaxation Exercises on Sleep Quality in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Study. Semin Oncol Nurs. 2024 Apr;40(2):151620. doi: 10.1016/j.soncn.2024.151620. Epub 2024 Mar 16.
- Background: PubMed 40378577Kotian PL, El-Kattan Y, Niwas S, Wu M, Lin TH, Bourdreaux B, Saini SK, Spaulding A, Kellogg-Yelder D, Parker C, Chambers-Wilson R, Bantia S, Miao Z, Williams J, Schmittou A, Raman K, Wiget PA, Chand P, Sudhakar Babu Y. Design, synthesis, and structure-activity relationships of selective biphenyl antithrombotic tissue factor/factor VIIa inhibitors. Eur J Med Chem. 2025 Sep 15;294:117708. doi: 10.1016/j.ejmech.2025.117708. Epub 2025 May 6.
- Background: PubMed 22424706Meltzer LJ, Montgomery-Downs HE, Insana SP, Walsh CM. Use of actigraphy for assessment in pediatric sleep research. Sleep Med Rev. 2012 Oct;16(5):463-75. doi: 10.1016/j.smrv.2011.10.002. Epub 2012 Mar 15.
- Background: PubMed 31121414Matricciani L, Paquet C, Galland B, Short M, Olds T. Children's sleep and health: A meta-review. Sleep Med Rev. 2019 Aug;46:136-150. doi: 10.1016/j.smrv.2019.04.011. Epub 2019 Apr 23.
- Background: PubMed 23348659Li HC, Williams PD, Williams AR, Chung JO, Chiu SY, Lopez V. Confirmatory factor analysis of the Chinese version of the Pediatric Quality-of-Life Inventory Cancer Module. Cancer Nurs. 2013 Nov-Dec;36(6):E66-72. doi: 10.1097/NCC.0b013e318276e056.
- Individual participant dataSharing planned: No. Some participants do not wish to share their information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education, Progressive Muscle Relaxation and Breathing exercises in people with Pediatrics Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuk Yan Mak (+852 62229509, nafertes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323069, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.