OncologyNCT06052904
Music Breathing for Caregivers of Children Newly Diagnosed With Cancer
A study testing mHealth-delivered music breathing therapy and Online educational modules in people with Oncology and Psychological Distress, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oncology, Psychological Distress
- What is being tested?
- mHealth-delivered music breathing therapy and Online educational modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Oct 2023to 2 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parental caregivers (the primary caregiver; either mother or father) who
- has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
- can read and communicate in Chinese (Cantonese or Mandarin)
- has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
- is willing to download and use Zoom as the intervention delivery platform.
Who cannot join
- has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
- is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
- is currently participating in any interventions or additional counselling services.
- has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth-delivered Music Breathing Therapy to Enhance Resilience and Improve Quality of Life of Caregivers of Children Newly Diagnosed With Cancer: A Pilot Randomized Controlled Trial
This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.
Read the detailed description
Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.
Aims:
- To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
- To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.
Hypotheses:
It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.
- Conditions
- Oncology, Psychological Distress
- Being tested
- mHealth-delivered music breathing therapy, Online educational modules
- Keywords
- Music breathing, Cancer, Caregivers, Children, Psychological distress, Resilience
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth-delivered music breathing therapyBehavioural
Parental caregivers in the intervention group will receive individual home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, by a qualified music therapist based on a standardized and validated music breathing instruction manual. The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing". In each session, participants will practice breathing for approximately 20-25 minutes in silence or with music in a sitting position. Thereafter, the participants will be instructed to create a Mandala drawing to visualize the effects of breathing on their mental body image, emotions, and thoughts. Each session will end with a debriefing session, which will serve to verbally integrate and reflect the participants' experiences and mental states.
Online educational modulesBehavioural
Participants in the control group will receive eight weekly online educational modules via email for 2 months. The content of the online educational modules will include medical information and advice about caring for a child who has been newly diagnosed with cancer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, an online video conferencing platform, by a qualified music therapist. Receives: Behavioral: mHealth-delivered music breathing therapy |
| Control group | Active comparator | Eight weekly online educational modules on medical information and advice about caring for a child who has been newly diagnosed with cancer via email for 2 months. Receives: Behavioral: Online educational modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates higher level of resilience.
Measured: 2-month after baseline (immediately after the intervention)
Resilience
The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates a higher level of resilience.
Measured: 6-month after baseline
Secondary outcomes (9)
Psychological distress (i.e., depression, anxiety and stress)
The Chinese version of the 21-item Depression Anxiety Stress Scale will be used to measure caregivers' mental health states of depression, anxiety, and stress over the past week. It is a set of three self-report scales, each of which comprises 7 items, rated on a 4-point Likert scale from 0 (did not apply at all over the last week) to 3 (applied very much or most of the time); a higher total score indicates a greater level of depression, anxiety and/or stress.
Measured: 2-month and 6-month after baseline
Caregiver strain
The Chinese version of the Modified Caregivers Strain Index will be used to assess the caregiver strain of the participants. Items rated on a 3-point Likert scale (0=no, 1=yes, sometimes, and 2=yes, always); a higher total score indicates a higher level of strain experienced by the caregiver.
Measured: 2-month and 6-month after baseline
Coping response
The Chinese version of the Brief Coping Orientation to Problems Experienced Inventory will be used to evaluate the coping responses of the parental caregivers. Items rated on a 4-point Likert scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot); a higher total score indicates a greater utilization of that specific type of coping strategy.
Measured: 2-month and 6-month after baseline
Caregiver's quality of life
World Health Organization Quality-of-Life Scale will be used to evaluate the quality of life of caregivers. Items are rated on a 5-point Likert scale from 1 to 5; a higher total score indicates a higher quality of life.
Measured: 2-month and 6-month after baseline
Feasibility outcomes - recruitment rate
Recruitment rates will be calculated as the number of participants who consented to participate in the study divided by the number of participants who meet the inclusion criteria.
Measured: Change from recruitment to 6-month follow-up
Feasibility outcomes - intervention engagement/adherence rate
Intervention engagement/adherence will be calculated as the number of participants who have completed the music breathing sessions and follow-up sessions, as well as spending at least once daily in performing self-practice music breathing throughout the 2-month intervention period, divided by the number of intervention group participants who have completed the study.
Measured: Change from recruitment to 6-month follow-up
Feasibility outcomes - Retention rate
Retention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.
Measured: Change from recruitment to 6-month follow-up
Acceptability - Satisfaction
Caregivers' perceived satisfaction will be assessed using an 12-item investigator-designed satisfaction survey, a higher total score indicates a higher level of satisfaction.
Measured: 2-month follow-up (immediately after intervention)
Acceptability
A semi-structured individual interview will be used to explore participants' perceptions and experiences of the intervention.
Measured: 2-month follow-up (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start3 Oct 2023
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
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
- 60 participants (actual)
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, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052904
- Sponsor's protocol ID
- PAED-2022-024
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 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
- mHealth-delivered Music Breathing Therapy to Enhance Resilience and Improve Quality of Life of Caregivers of Children Newly Diagnosed With Cancer: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06052904
- Acronym / sponsor ID
- PAED-2022-024
- Conditions
- Oncology, Psychological Distress
- Keywords
- Music breathing, Cancer, Caregivers, Children, Psychological distress, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 25 Sep 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.
This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.
Detailed description
Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.
Aims:
- To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
- To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.
Hypotheses:
It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.
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 | Behavioral: mHealth-delivered music breathing therapyHome-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, an online video conferencing platform, by a qualified music therapist. |
| Control group | Active comparator | Behavioral: Online educational modulesEight weekly online educational modules on medical information and advice about caring for a child who has been newly diagnosed with cancer via email for 2 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parental caregivers (the primary caregiver; either mother or father) who
- has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
- can read and communicate in Chinese (Cantonese or Mandarin)
- has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
- is willing to download and use Zoom as the intervention delivery platform.
Key exclusion criteria (4 listed)
- has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
- is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
- is currently participating in any interventions or additional counselling services.
- has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications
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 |
|---|---|---|
| mHealth-delivered music breathing therapyParental caregivers in the intervention group will receive individual home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, by a qualified music therapist based on a standardized and validated music breathing instruction manual. The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing". In each session, participants will practice breathing for approximately 20-25 minutes in silence or with music in a sitting position. Thereafter, the participants will be instructed to create a Mandala drawing to visualize the effects of breathing on their mental body image, emotions, and thoughts. Each session will end with a debriefing session, which will serve to verbally integrate and reflect the participants' experiences and mental states. | Behavioural | Intervention group |
| Online educational modulesParticipants in the control group will receive eight weekly online educational modules via email for 2 months. The content of the online educational modules will include medical information and advice about caring for a child who has been newly diagnosed with cancer. | Behavioural | Control group |
Primary outcome
Resilience
Time frame: 2-month after baseline (immediately after the intervention)
The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates higher level of resilience.
Resilience
Time frame: 6-month after baseline
The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates a higher level of resilience.
9 secondary outcomes
Psychological distress (i.e., depression, anxiety and stress)
Time frame: 2-month and 6-month after baseline
Caregiver strain
Time frame: 2-month and 6-month after baseline
Coping response
Time frame: 2-month and 6-month after baseline
Caregiver's quality of life
Time frame: 2-month and 6-month after baseline
Feasibility outcomes - recruitment rate
Time frame: Change from recruitment to 6-month follow-up
Feasibility outcomes - intervention engagement/adherence rate
Time frame: Change from recruitment to 6-month follow-up
Feasibility outcomes - Retention rate
Time frame: Change from recruitment to 6-month follow-up
Acceptability - Satisfaction
Time frame: 2-month follow-up (immediately after intervention)
Acceptability
Time frame: 2-month follow-up (immediately after intervention)
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 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. This study is not recruiting at the moment.
Ankie Tan Cheung principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth-delivered music breathing therapy and Online educational modules in people with Oncology and Psychological Distress, 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 5 inclusion and 4 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 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 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?
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?
Resilience (time frame: 2-month after baseline (immediately after the intervention)). The study lists 2 primary outcomes in all. 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.