OncologyNCT05748210
A Symptom Management Application for Children at the Early Stage of Cancer Survivorship and Their Caregivers
A study testing Symptom management mobile health application with personalised support and Wait-list Symptom management mobile health application with personalised support in people with Oncology and Survivorship, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The goal of this randomized controlled trial is to examine the efficacy of the mHealth app in improving symptoms experienced by children in the early stage of cancer survivorship, including physical function, anxiety, depressive symptoms, fatigue, peer relationships, and pain interference, and at improving the quality… Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Oncology, Survivorship
- What is being tested?
- Symptom management mobile health application with personalised support and Wait-list Symptom management mobile health application with personalised support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesHong Kong
- Study dates
- 2 Jan 2025to 30 Nov 2025
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chinese paediatric cancer survivors will be included if they
- are aged 9 to 16 years,
- are able to read Chinese and communicate in Chinese,
- have completed active cancer treatment (within the previous 2 years), as early symptom management support is crucial to reduce the symptom burden in survivors and their caregivers throughout their survivorship, and
- have a smartphone or tablet and are willing to install the mHealth app.
- The primary caregiver of the paediatric cancer survivors (either the mother or father)
- are able to read Chinese and communicate in Chinese, and
- have a smartphone or tablet and are willing to install the mHealth app with their children surviving cancer.
Who cannot join
- Chinese paediatric cancer survivors will be excluded if they
- have cognitive impairments or psychiatric illnesses
- are currently participating in other symptom management studies, or
- have evidence of secondary malignancy or recurrence
- The primary caregivers of the paediatric cancer survivors (either the mother or father) will be excluded if they have cognitive impairments or psychiatric illnesses.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
The Chinese University of Hong Kong
Hong Kong
Ankie Tan Cheung, PhD, 852 39430515, ankiecheung@cuhk.edu.hk
William Ho Cheung Li, PhD, 852 39430889, williamli@cuhk.edu.hk
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Tan Cheung, 852 39430515, ankiecheung@cuhk.edu.hk
About this study
Official title: Development and Evaluation of a Symptom Management Mobile Health Application With Personalised Support for Children at the Early Stage of Cancer Survivorship and Their Caregivers
The goal of this randomized controlled trial is to examine the efficacy of the mHealth app in improving symptoms experienced by children in the early stage of cancer survivorship, including physical function, anxiety, depressive symptoms, fatigue, peer relationships, and pain interference, and at improving the quality of life (QoL) of the children's primary caregivers
The main question it aims to answer is whether survivors who receive the symptom management mHealth app intervention will report improved symptoms, i.e., improved physical function; lower levels of anxiety, depressive symptoms, and fatigue; better peer relationships; and lower pain interference 3 months after starting the intervention. Additionally, we hypothesized that the primary caregivers (either the mother or father) would report an improved QoL 3 months after starting the intervention.
Participants in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. They are required to complete questionnaires at baseline (during medical follow-up), 1, 2, and 3 months (via electronic-based systems in the mobile app) Besides, semi-structured interviews and will be conducted to examine the usability, feasibility, and acceptability of the intervention.
Read the detailed description
In Hong Kong, the incidence of paediatric cancer has been increasing in the past few years, from 180 new cancer cases in 2017 to 196 cases in 2019 [1]. The average 5-year survival rate for paediatric cancer patients is approximately 85% due to recent advances in cancer treatments [2]. The success of these treatments has resulted in a rapid growth in the population of paediatric cancer survivors globally. This population now has an average lifespan of 72 years [2]. Despite the improved survival rate, the high toxicity and low specificity of cancer treatment given at an early age induce a myriad of deleterious late effects that have a detrimental impact on survivors' physical and psychosocial well-being [3-5]. Therefore, children who have completed cancer treatment require ongoing monitoring for cancer progression and survivorship care as early as possible to manage the symptoms induced by the invasive treatment. Symptom management in paediatric oncology nursing is becoming increasingly important due to the complex treatment modalities. The benefits of effective symptom management, particularly improvements in physical functioning and reduced psychological distress, are exponential for children being treated for cancer and their caregivers throughout the cancer trajectory.
Paediatric oncology patients receive close monitoring of their somatic symptoms during their hospital stay, but there is a paucity of symptom management for children who have completed treatment and are at the early stage of survivorship. During the transition from hospital stay to home care, children and their caregivers may experience significant psychological distress due to their concerns about the child's health and uncertainties about coping with the potential symptom burden or cancer recurrence. During the first year after completing cancer treatment, many side effects related to the cancer or its treatment may persist, and other late effects may also develop [3]. The unmet needs for symptom monitoring and management for paediatric cancer survivors, particularly those in the early stage of survivorship, warrant immediate attention from healthcare professionals. It is imperative for healthcare professionals to engage in the rigorous planning, development, and implementation of appropriate interventions to support symptom management for children in the early stage of cancer survivorship and their caregivers. These interventions should be implemented at discharge to manage patient-reported symptoms and improve the children's QoL and survival rate.
Given the high utilisation of mobile technologies, integrating mobile technologies into current cancer survivorship care may be a promising and flexible approach for symptom management for children in the early stage of cancer survivorship and their caregivers. Digital health interventions have been shown to be effective at improving patient-reported outcomes in various patient populations, but there is a lack of such an intervention for paediatric cancer survivors and their caregivers to ameliorate their symptom burden in their local contexts (e.g., at home). The proposed study aims to develop a symptom management mHealth app to support children in the early stage of cancer survivorship and their caregivers and to evaluate its usability, feasibility, acceptability, and efficacy.
- Conditions
- Oncology, Survivorship
- Being tested
- Symptom management mobile health application with personalised support, Wait-list Symptom management mobile health application with personalised support
- Keywords
- symptom management, cancer, children, caregiver, mobile health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom management mobile health application with personalised supportOther
Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms.
The app will comprise several interactive elements to provide children and their caregivers with real-time symptom management support. Comprehensive educational materials regarding cancer and its treatment side effects, including possible symptoms, functional limitations, and psychological responses, will be provided in the app for the children and their caregivers to gain a thorough understanding of the potential symptom burden that they may experience.
Wait-list Symptom management mobile health application with personalised supportOther
To ensure the equity of access to a potentially desirable and effective intervention (i.e., mHeath app for symptom management), participants in the wait-list control group will be invited to receive the same intervention as participants in the intervention group after the completion of all assessments on a voluntary basis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms. Receives: Other: Symptom management mobile health application with personalised support |
| Wait-list control group | Active comparator | To ensure the equity of access to a potentially desirable and effective intervention (i.e., mHeath app for symptom management), participants in the wait-list control group will be invited to receive the same intervention as participants in the intervention group after the completion of all assessments on a voluntary basis. Receives: Other: Wait-list Symptom management mobile health application with personalised support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of child's symptoms
The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships.
Measured: 3 months after starting the intervention
Secondary outcomes (2)
Severity of child's symptoms
The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships.
Measured: 1 and 2 months after starting the intervention
Caregivers' quality of life
Primary caregivers' quality of life will be assessed using the Chinese version of the World Health Organization's Quality of Life Instrument at baseline and 3 months after starting the intervention. It is a generic health status measure in assessing the overall QoL and general health (2 items), physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items) using a five-point Likert scale. The item scores were added to calculate the domain scores, where a higher score indicates better quality of life.
Measured: 1, 2 and 3 months after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start2 Jan 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Tan, Chinese University of Hong Kong
- Investigators
- Ankie Tan Cheung, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748210
- Sponsor's protocol ID
- PAED-2022-010
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Symptom Management Mobile Health Application With Personalised Support for Children at the Early Stage of Cancer Survivorship and Their Caregivers
- ClinicalTrials.gov ID
- NCT05748210
- Acronym / sponsor ID
- PAED-2022-010
- Conditions
- Oncology, Survivorship
- Keywords
- symptom management, cancer, children, caregiver, mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 28 Feb 2023 (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.
The goal of this randomized controlled trial is to examine the efficacy of the mHealth app in improving symptoms experienced by children in the early stage of cancer survivorship, including physical function, anxiety, depressive symptoms, fatigue, peer relationships, and pain interference, and at improving the quality of life (QoL) of the children's primary caregivers
The main question it aims to answer is whether survivors who receive the symptom management mHealth app intervention will report improved symptoms, i.e., improved physical function; lower levels of anxiety, depressive symptoms, and fatigue; better peer relationships; and lower pain interference 3 months after starting the intervention. Additionally, we hypothesized that the primary caregivers (either the mother or father) would report an improved QoL 3 months after starting the intervention.
Participants in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. They are required to complete questionnaires at baseline (during medical follow-up), 1, 2, and 3 months (via electronic-based systems in the mobile app) Besides, semi-structured interviews and will be conducted to examine the usability, feasibility, and acceptability of the intervention.
Detailed description
In Hong Kong, the incidence of paediatric cancer has been increasing in the past few years, from 180 new cancer cases in 2017 to 196 cases in 2019 [1]. The average 5-year survival rate for paediatric cancer patients is approximately 85% due to recent advances in cancer treatments [2]. The success of these treatments has resulted in a rapid growth in the population of paediatric cancer survivors globally. This population now has an average lifespan of 72 years [2]. Despite the improved survival rate, the high toxicity and low specificity of cancer treatment given at an early age induce a myriad of deleterious late effects that have a detrimental impact on survivors' physical and psychosocial well-being [3-5]. Therefore, children who have completed cancer treatment require ongoing monitoring for cancer progression and survivorship care as early as possible to manage the symptoms induced by the invasive treatment. Symptom management in paediatric oncology nursing is becoming increasingly important due to the complex treatment modalities. The benefits of effective symptom management, particularly improvements in physical functioning and reduced psychological distress, are exponential for children being treated for cancer and their caregivers throughout the cancer trajectory.
Paediatric oncology patients receive close monitoring of their somatic symptoms during their hospital stay, but there is a paucity of symptom management for children who have completed treatment and are at the early stage of survivorship. During the transition from hospital stay to home care, children and their caregivers may experience significant psychological distress due to their concerns about the child's health and uncertainties about coping with the potential symptom burden or cancer recurrence. During the first year after completing cancer treatment, many side effects related to the cancer or its treatment may persist, and other late effects may also develop [3]. The unmet needs for symptom monitoring and management for paediatric cancer survivors, particularly those in the early stage of survivorship, warrant immediate attention from healthcare professionals. It is imperative for healthcare professionals to engage in the rigorous planning, development, and implementation of appropriate interventions to support symptom management for children in the early stage of cancer survivorship and their caregivers. These interventions should be implemented at discharge to manage patient-reported symptoms and improve the children's QoL and survival rate.
Given the high utilisation of mobile technologies, integrating mobile technologies into current cancer survivorship care may be a promising and flexible approach for symptom management for children in the early stage of cancer survivorship and their caregivers. Digital health interventions have been shown to be effective at improving patient-reported outcomes in various patient populations, but there is a lack of such an intervention for paediatric cancer survivors and their caregivers to ameliorate their symptom burden in their local contexts (e.g., at home). The proposed study aims to develop a symptom management mHealth app to support children in the early stage of cancer survivorship and their caregivers and to evaluate its usability, feasibility, acceptability, and efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Symptom management mobile health application with personalised supportChild-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms. |
| Wait-list control group | Active comparator | Other: Wait-list Symptom management mobile health application with personalised supportTo ensure the equity of access to a potentially desirable and effective intervention (i.e., mHeath app for symptom management), participants in the wait-list control group will be invited to receive the same intervention as participants in the intervention group after the completion of all assessments on a voluntary basis. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Chinese paediatric cancer survivors will be included if they
- are aged 9 to 16 years,
- are able to read Chinese and communicate in Chinese,
- have completed active cancer treatment (within the previous 2 years), as early symptom management support is crucial to reduce the symptom burden in survivors and their caregivers throughout their survivorship, and
- have a smartphone or tablet and are willing to install the mHealth app.
Key exclusion criteria (5 listed)
- Chinese paediatric cancer survivors will be excluded if they
- have cognitive impairments or psychiatric illnesses
- are currently participating in other symptom management studies, or
- have evidence of secondary malignancy or recurrence
- The primary caregivers of the paediatric cancer survivors (either the mother or father) will be excluded if they have cognitive impairments or psychiatric illnesses.
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 |
|---|---|---|
| Symptom management mobile health application with personalised supportChild-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms. The app will comprise several interactive elements to provide children and their caregivers with real-time symptom management support. Comprehensive educational materials regarding cancer and its treatment side effects, including possible symptoms, functional limitations, and psychological responses, will be provided in the app for the children and their caregivers to gain a thorough understanding of the potential symptom burden that they may experience. | Other | Intervention group |
| Wait-list Symptom management mobile health application with personalised supportTo ensure the equity of access to a potentially desirable and effective intervention (i.e., mHeath app for symptom management), participants in the wait-list control group will be invited to receive the same intervention as participants in the intervention group after the completion of all assessments on a voluntary basis. | Other | Wait-list control group |
Primary outcome
Severity of child's symptoms
Time frame: 3 months after starting the intervention
The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships.
2 secondary outcomes
Severity of child's symptoms
Time frame: 1 and 2 months after starting the intervention
Caregivers' quality of life
Time frame: 1, 2 and 3 months after starting the intervention
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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Ankie Tan Cheung, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom management mobile health application with personalised support and Wait-list Symptom management mobile health application with personalised support in people with Oncology and Survivorship, run by Chinese University of Hong Kong at 2 sites 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 8 inclusion and 5 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ankie Tan Cheung, PhD (852 3943 0515, ankiecheung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of child's symptoms (time frame: 3 months after starting the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.