Child With CancerNCT05765643
Nurse Parental Support Using a Mobile App in Symptom Management for CMC
A study testing Nurse parental support in symptom management using a mobile health App in people with Child With Cancer and Muscular Atrophy, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial summary
Parents of children with medical complexity (CMC) are suffering from high level of stress. These CMC get multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy
- What is being tested?
- Nurse parental support in symptom management using a mobile health App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesHong Kong
- Study dates
- 15 Aug 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The eligible criteria for parents are:
- parent of a child with medical complexity aged 2-18
- having a Smartphone
- able to communicate in Chinese and read Chinese
- living with his/her child at home.
Who cannot join
- The exclusion criteria for parents are
- a reported mental health disorder
- engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
School of Nursing
Hong Kong, 852
School of Nursing The Hong Kong Polytechnic University
Kowloon, Kowloon, 852
About this study
Official title: Is Nurse Parental Support Using a Proactive Mobile Health Application More Effective Than Usual Community Care in Enhancing Parental Self-efficacy in Symptom Management for the CMC in Communities: A RCT
Parents of children with medical complexity (CMC) are suffering from high level of stress. These CMC get multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. They experience one or more physical and psychological symptoms at one time, which seriously affect their quality of life and increase their health services utilization. Parents may lack confidence in their abilities when managing their child's symptoms. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve child's health status. Home-based nursing services for the CMC and parents are available in Hong Kong. However, the service faces challenges because of serious nursing workforce shortage and the recent coronavirus pandemic. Nurse parental support in symptom management using a proactive mobile health App is an alternative method considered more feasible to continue home-based support for the CMC and parents.
This proposed RCT will test the effects of a nurse-led mobile App for enhancing parental self-efficacy in symptom management for CMC. A repeated-measures, two-group design will be used to evaluate the effects between intervention and wait-listed control groups by comparing the study group receiving nurse support using a mobile App, and the wait-listed control group receiving usual community care for 96 randomly selected parents over a three-month follow-up. Primary outcome is parental self-efficacy. Secondary outcomes include children's symptom burden and health services utilization. These factors will be measured before intervention, immediately after intervention and three-month after intervention. The effectiveness of the intervention will be evaluated by comparing the primary outcome at three-month after intervention across the two study groups using ANCOVA with control for the pre-test value of parental self-efficacy. Generalized estimating equation will be used to address secondary objectives regarding the effectiveness of the mobile App as compared to the control on secondary outcomes from T1 to T3 with appropriate link function. It is hypothesized that nurse support using the mobile App is more effective than usual community care in enhancing parental self-efficacy in symptom management for their CMC at three-month after intervention.
- Conditions
- Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity
- Being tested
- Nurse parental support in symptom management using a mobile health App
- Keywords
- Child with medical complexity, Child with cancer, parental self-efficacy, mobile health application, symptom management
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse parental support in symptom management using a mobile health AppOther
Parents in this group will receive a mobile App that includes health assessment, monitoring, health education and nurse support using phone calls over a 3-month period
| Study group | Role | What they receive |
|---|---|---|
| Nurse parental support in symptom management using a mobile health App over 3 months | Experimental | Not described Receives: Other: Nurse parental support in symptom management using a mobile health App |
| Wait-listed control | No intervention | Parents in this group can join the usual community social or health care services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of caregiver self-efficacy
The CaSES (Chinese version) is a 18-item scale. It is rated on a 9-point scale, with 1= no confidence, to 9 =full confidence.
Measured: 0, week 12, week 24
Secondary outcomes (2)
Change of children health service utilization
This is a record used to summarize a child's visits to outpatient clinic and emergency room, and the child's admission history.
Measured: 0, week 12, week 24
Change of children's symptom burden
This is a modified 40-item Memorial Symptom Assessment Scale (MSAS in Chinese version). The items for measuring the frequency and severity of symptoms are rated on a 4-point Likert scale from one (almost never) to four (always). The items for measuring distress are rated on a 5-point Likert scale from one (not at all) to five (very).
Measured: 0, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Aug 2023
- Primary completion30 Dec 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child With CancerStudies of the same condition, open and under way.
- 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
- Model description
- This is a single-blinded, randomized controlled trial with two-armed repeated measures
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Dr Winsome Lam, The Hong Kong Polytechnic University
- Investigators
- Lam Winsome, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765643
- Sponsor's protocol ID
- HSEARS20220721005
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lam W, Zhao Z, Law QP, Ngai VW, Wong FK, Fowler C. Nurse-led proactive mobile application in symptom management for children with medical complexity: Study protocol for a randomized controlled trial. J Adv Nurs. 2024 Sep;80(9):3856-3865. doi: 10.1111/jan.16294.
PubMed 39118424
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Nurse Parental Support Using a Proactive Mobile Health Application More Effective Than Usual Community Care in Enhancing Parental Self-efficacy in Symptom Management for the CMC in Communities: A RCT
- ClinicalTrials.gov ID
- NCT05765643
- Acronym / sponsor ID
- HSEARS20220721005
- Conditions
- Child With Cancer, Muscular Atrophy, Child With Cerebral Palsy, Child With Medical Complexity
- Keywords
- Child with medical complexity, Child with cancer, parental self-efficacy, mobile health application, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 13 Mar 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.
Parents of children with medical complexity (CMC) are suffering from high level of stress. These CMC get multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. They experience one or more physical and psychological symptoms at one time, which seriously affect their quality of life and increase their health services utilization. Parents may lack confidence in their abilities when managing their child's symptoms. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve child's health status. Home-based nursing services for the CMC and parents are available in Hong Kong. However, the service faces challenges because of serious nursing workforce shortage and the recent coronavirus pandemic. Nurse parental support in symptom management using a proactive mobile health App is an alternative method considered more feasible to continue home-based support for the CMC and parents.
This proposed RCT will test the effects of a nurse-led mobile App for enhancing parental self-efficacy in symptom management for CMC. A repeated-measures, two-group design will be used to evaluate the effects between intervention and wait-listed control groups by comparing the study group receiving nurse support using a mobile App, and the wait-listed control group receiving usual community care for 96 randomly selected parents over a three-month follow-up. Primary outcome is parental self-efficacy. Secondary outcomes include children's symptom burden and health services utilization. These factors will be measured before intervention, immediately after intervention and three-month after intervention. The effectiveness of the intervention will be evaluated by comparing the primary outcome at three-month after intervention across the two study groups using ANCOVA with control for the pre-test value of parental self-efficacy. Generalized estimating equation will be used to address secondary objectives regarding the effectiveness of the mobile App as compared to the control on secondary outcomes from T1 to T3 with appropriate link function. It is hypothesized that nurse support using the mobile App is more effective than usual community care in enhancing parental self-efficacy in symptom management for their CMC at three-month after intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-blinded, randomized controlled trial with two-armed repeated measures
| Arm | Type | Receives |
|---|---|---|
| Nurse parental support in symptom management using a mobile health App over 3 months | Experimental | Other: Nurse parental support in symptom management using a mobile health App |
| Wait-listed control | No intervention | –Parents in this group can join the usual community social or health care services as usual. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- parent of a child with medical complexity aged 2-18
- having a Smartphone
- able to communicate in Chinese and read Chinese
- living with his/her child at home.
Key exclusion criteria (3 listed)
- The exclusion criteria for parents are
- a reported mental health disorder
- engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.
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 |
|---|---|---|
| Nurse parental support in symptom management using a mobile health AppParents in this group will receive a mobile App that includes health assessment, monitoring, health education and nurse support using phone calls over a 3-month period | Other | Nurse parental support in symptom management using a mobile health App over 3 months |
Primary outcome
Change of caregiver self-efficacy
Time frame: 0, week 12, week 24
The CaSES (Chinese version) is a 18-item scale. It is rated on a 9-point scale, with 1= no confidence, to 9 =full confidence.
2 secondary outcomes
Change of children health service utilization
Time frame: 0, week 12, week 24
Change of children's symptom burden
Time frame: 0, week 12, week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 39118424Lam W, Zhao Z, Law QP, Ngai VW, Wong FK, Fowler C. Nurse-led proactive mobile application in symptom management for children with medical complexity: Study protocol for a randomized controlled trial. J Adv Nurs. 2024 Sep;80(9):3856-3865. doi: 10.1111/jan.16294.
- 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. This study is not recruiting at the moment.
Lam Winsome, PhD principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse parental support in symptom management using a mobile health App in people with Child With Cancer and Muscular Atrophy, run by The Hong Kong Polytechnic University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of caregiver self-efficacy (time frame: 0, week 12, week 24). 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 NCT05765643, which also lists 1 linked publication.
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 17 Sep 2026.