Brain NeoplasmsNCT03399864
Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors
A study testing musical training in people with Brain Neoplasms and Child, run by The University of Hong Kong at 1 site in China.
Trial summary
This study aims to work out the effectiveness (effect size) of the musical training intervention in reducing depressive symptoms, improving self-esteem and quality of life among childhood brain tumour survivors and to examine the feasibility, appropriateness, and acceptability of implementing musical training… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Brain Neoplasms, Child
- What is being tested?
- musical training
- 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 siteChina
- Study dates
- 20 Feb 2017to 30 Jun 2018
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hong Kong Chinese children surviving from brain tumours with the Modified Mini-Mental Scale (MMSE) score of 18 or above
- be aged between 7 and 16 years
- able to speak Cantonese and read Chinese
- have completed treatment for at least two months
- have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
Who cannot join
- children who have undertaken any musical training following their cancer diagnosis
- survivors with evidence of recurrence or second malignancies
- survivors receiving palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Musical Training in Reducing Depressive Symptoms, Enhancing Self-esteem and Quality of Life Among Hong Kong Chinese Childhood Brain Tumor Survivors - A Pilot Randomized Controlled Trial
This study aims to work out the effectiveness (effect size) of the musical training intervention in reducing depressive symptoms, improving self-esteem and quality of life among childhood brain tumour survivors and to examine the feasibility, appropriateness, and acceptability of implementing musical training intervention in clinical practice. Subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), while those in the control group will receive usual care.
Read the detailed description
Musical training has been increasingly implemented to promote one's psychological well-being and cognitive functioning. For instance, to reduce depression, anxiety in psychiatric patients, to improve self-esteem and mood recognition in hospitalized adolescent patients diagnosed with "adjustment reaction to adolescence", to improve social skills of children with autism, to enhance reading skills and academic achievement in young poor readers, and to facilitate children's cognitive development. Nevertheless, the effectiveness of musical training in promoting psychological well-being, particularly to reduce their depressive symptoms and enhance self-esteem, and enhancing quality of life among the childhood brain tumour survivors is remain underexplored. It is of paramount importance to examine the effectiveness of musical training so as to ameliorate adverse disease- and treatment-related late effects, such as depression and low self-esteem, hence enhancing childhood brain tumour survivors' quality of life.
- Conditions
- Brain Neoplasms, Child
- Being tested
- musical training, usual care
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musical trainingBehavioural
The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.
usual careOther
The subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Apart from receiving scheduled medical follow-up, the subjects in the experimental group will receive a weekly 45-minute lesson on musical training for 52 weeks. The musical training will be conducted by the Music Children Foundation and be implemented in a ratio of one subject to one qualified orchestral performer at the subjects' homes. A musical instrument will be assigned to each subject based on their interests and the results of the prior assessment of subjects' expiratory function and fine motor skills. The musical training will start at the lowest level, such as hitting simple notes and end at the highest level, such as playing an entire song. Receives: Behavioral: musical training |
| Control group | Other | The subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.
The subjects' depressive symptoms will be assessed at 12-month after starting the intervention using the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC).
The CES-DC is a commonly used tool in assessing the number of depressive symptoms of children and adolescent (Radloff, 1977). It consists of 20 items which are rated on a 4-point Likert scale from 0 to 3 (0= "not at all", 1 = "a little", 2 = "sometimes", 3= "a lot") regarding the subjects' feelings and experiences of last week. A possible scores ranging from 0 to 60 will be obtained after summing up all the items. Higher scores indicate greater number of depressive symptoms experienced. The cut-off score of this scale is 16, which indicates the children or the adolescents are currently experiencing a significant level of depressive symptoms.
Measured: 12-month follow-up
Secondary outcomes (8)
Depressive symptoms at baseline between intervention and control group
Subjects' depressive symptoms will be assessed at baseline using the Center for Epidemiological Studies Depression Scale for Children (CES-DC).
The CES-DC is a commonly used tool in assessing the number of depressive symptoms of children and adolescent. It consists of 20 items which are rated on a 4-point Likert scale from 0 to 3 (0= "not at all", 1 = "a little", 2 = "sometimes", 3= "a lot") regarding the subjects' feelings and experiences of last week. A possible scores ranging from 0 to 60 will be obtained after summing up all the items. Higher scores indicate greater number of depressive symptoms experienced. The cut-off score of this scale is 16, which indicates the children or the adolescents are currently experiencing a significant level of depressive symptoms. Subjects will be asked to respond to the Chinese version of the CES-DC at baseline.
Measured: baseline
Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group
Change in depressive symptoms will be assessed at 6-month after starting the intervention using the Center for Epidemiological Studies Depression Scale for Children (CES-DC).
The CES-DC is a commonly used tool in assessing the number of depressive symptoms of children and adolescent. It consists of 20 items which are rated on a 4-point Likert scale from 0 to 3 (0= "not at all", 1 = "a little", 2 = "sometimes", 3= "a lot") regarding the subjects' feelings and experiences of last week. A possible scores ranging from 0 to 60 will be obtained after summing up all the items. Higher scores indicate greater number of depressive symptoms experienced. The cut-off score of this scale is 16, which indicates the children or the adolescents are currently experiencing a significant level of depressive symptoms. Subjects will be asked to respond to the Chinese version of the CES-DC at 6-month after starting the intervention.
Measured: 6-month follow-up
Level of self-esteem at baseline between intervention and control group
The subjects' self-esteem will be assessed at baseline, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).
The RSES is a tool designed to measure the global self-esteem of children and adolescent. The scale contains 10 items, which are rated on a 4-point Likert scale with score 1 to 4 (1= "strongly disagree", 2= "disagree", 3= "agree", 4 = "strongly agree"), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem. Subjects will be asked to respond to the Chinese version of the RSES at baseline.
Measured: baseline
Change in level of self-esteem from baseline at 6-month between intervention and control group
The subjects' self-esteem will be assessed at 6-month follow-up, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).
The RSES is a tool designed to measure the global self-esteem of children and adolescent. The scale contains 10 items, which are rated on a 4-point Likert scale with score 1 to 4 (1= "strongly disagree", 2= "disagree", 3= "agree", 4 = "strongly agree"), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem. Subjects will be asked to respond to the Chinese version of the RSES at 6-month after starting the intervention.
Measured: 6-month follow-up
Change in level of self-esteem from baseline at 12-month between intervention and control group
The subjects' self-esteem will be assessed at 12-month follow-up, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).
The RSES is a tool designed to measure the global self-esteem of children and adolescent. The scale contains 10 items, which are rated on a 4-point Likert scale with score 1 to 4 (1= "strongly disagree", 2= "disagree", 3= "agree", 4 = "strongly agree"), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem. Subjects will be asked to respond to the Chinese version of the RSES at 12-month after starting the intervention.
Measured: 12-month follow-up
Quality of life at baseline between intervention and control group
The subjects' quality of life will be assessed at baseline, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's health-related quality of life. The scale consists of 23 items which are categorized into four dimensions, namely physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). All items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always) by which the participants will be asked how much of a problem has been experienced over the last month. A total possible scores ranging from 0 to 100 will be obtained, with higher scores indicating better health-related quality of life. Subjects will be asked to respond to the Chinese version of the PedsQL 4.0 at baseline.
Measured: baseline
Change in Quality of life at 6-month follow-up between intervention and control group
The subjects' quality of life will be assessed at 6-month after starting the intervention, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's health-related quality of life. The scale consists of 23 items which are categorized into four dimensions, namely physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). All items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always) by which the participants will be asked how much of a problem has been experienced over the last month. A total possible scores ranging from 0 to 100 will be obtained, with higher scores indicating better health-related quality of life. Subjects will be asked to respond to the Chinese version of the PedsQL 4.0 at 6-month after starting the intervention.
Measured: 6-month follow-up
Change in Quality of life at 12-month follow-up between intervention and control group
The subjects' quality of life will be assessed at 12-month after starting the intervention, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's health-related quality of life. The scale consists of 23 items which are categorized into four dimensions, namely physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). All items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always) by which the participants will be asked how much of a problem has been experienced over the last month. A total possible scores ranging from 0 to 100 will be obtained, with higher scores indicating better health-related quality of life. Subjects will be asked to respond to the Chinese version of the PedsQL 4.0 at 12-month after starting the intervention.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start20 Feb 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by The 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
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399864
- Sponsor's protocol ID
- UW16-023_2
- Status last verified
- Jun 2019
- First submitted
- 8 Jan 2018
- Last updated
- 12 Jun 2019
- 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 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Musical Training in Reducing Depressive Symptoms, Enhancing Self-esteem and Quality of Life Among Hong Kong Chinese Childhood Brain Tumor Survivors - A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03399864
- Acronym / sponsor ID
- UW16-023_2
- Conditions
- Brain Neoplasms, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Jan 2018 (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 study aims to work out the effectiveness (effect size) of the musical training intervention in reducing depressive symptoms, improving self-esteem and quality of life among childhood brain tumour survivors and to examine the feasibility, appropriateness, and acceptability of implementing musical training intervention in clinical practice. Subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), while those in the control group will receive usual care.
Detailed description
Musical training has been increasingly implemented to promote one's psychological well-being and cognitive functioning. For instance, to reduce depression, anxiety in psychiatric patients, to improve self-esteem and mood recognition in hospitalized adolescent patients diagnosed with "adjustment reaction to adolescence", to improve social skills of children with autism, to enhance reading skills and academic achievement in young poor readers, and to facilitate children's cognitive development. Nevertheless, the effectiveness of musical training in promoting psychological well-being, particularly to reduce their depressive symptoms and enhance self-esteem, and enhancing quality of life among the childhood brain tumour survivors is remain underexplored. It is of paramount importance to examine the effectiveness of musical training so as to ameliorate adverse disease- and treatment-related late effects, such as depression and low self-esteem, hence enhancing childhood brain tumour survivors' quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: musical trainingApart from receiving scheduled medical follow-up, the subjects in the experimental group will receive a weekly 45-minute lesson on musical training for 52 weeks. The musical training will be conducted by the Music Children Foundation and be implemented in a ratio of one subject to one qualified orchestral performer at the subjects' homes. A musical instrument will be assigned to each subject based on their interests and the results of the prior assessment of subjects' expiratory function and fine motor skills. The musical training will start at the lowest level, such as hitting simple notes and end at the highest level, such as playing an entire song. |
| Control group | Other | Other: usual careThe subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hong Kong Chinese children surviving from brain tumours with the Modified Mini-Mental Scale (MMSE) score of 18 or above
- be aged between 7 and 16 years
- able to speak Cantonese and read Chinese
- have completed treatment for at least two months
- have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
Key exclusion criteria (3 listed)
- children who have undertaken any musical training following their cancer diagnosis
- survivors with evidence of recurrence or second malignancies
- survivors receiving palliative care
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 |
|---|---|---|
| musical trainingThe subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks. | Behavioural | Experimental group |
| usual careThe subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units. | Other | Control group |
Primary outcome
Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.
Time frame: 12-month follow-up
The subjects' depressive symptoms will be assessed at 12-month after starting the intervention using the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC). The CES-DC is a commonly used tool in assessing the number of depressive symptoms of children and adolescent (Radloff, 1977). It consists of 20 items which are rated on a 4-point Likert scale from 0 to 3 (0= "not at all", 1 = "a little", 2 = "sometimes", 3= "a lot") regarding the subjects' feelings and experiences of last week. A possible scores ranging from 0 to 60 will be obtained after summing up all the items. Higher scores indicate greater number of depressive symptoms experienced. The cut-off score of this scale is 16, which indicates the children or the adolescents are currently experiencing a significant level of depressive symptoms.
8 secondary outcomes
Depressive symptoms at baseline between intervention and control group
Time frame: baseline
Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
Level of self-esteem at baseline between intervention and control group
Time frame: baseline
Change in level of self-esteem from baseline at 6-month between intervention and control group
Time frame: 6-month follow-up
Change in level of self-esteem from baseline at 12-month between intervention and control group
Time frame: 12-month follow-up
Quality of life at baseline between intervention and control group
Time frame: baseline
Change in Quality of life at 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
Change in Quality of life at 12-month follow-up between intervention and control group
Time frame: 12-month follow-up
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 12 Jun 2019.
- 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.
Ho Cheung William Li principal investigator
The 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 musical training in people with Brain Neoplasms and Child, run by The University of Hong Kong at 1 site in China.
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 12 Jun 2019. 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 China. 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 in depressive symptoms from baseline at 12-month follow-up between intervention and control group. (time frame: 12-month follow-up). 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 12 Jun 2019.