Brain NeoplasmsNCT02754908
Effectiveness of Musical Training in Children Surviving Brain Tumours
A study testing musical training and tutoring classes 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 examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls. Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Brain Neoplasms, Child
- What is being tested?
- musical training and tutoring classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- surviving germ cell tumours of the brain
- be aged from 7 to 19 years
- be able to speak Cantonese and read Chinese
- have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
- have completed treatment for at least two months
Who cannot join
- have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
- with evidence of cancer recurrence or second malignancy in their medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Musical Training in the Improvement of the Neurocognitive Function and Psychological Well-being of Children Surviving Brain Tumours
This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.
Read the detailed description
Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.
Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.
- Conditions
- Brain Neoplasms, Child
- Being tested
- musical training, tutoring classes
- 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 one year (52 weeks), conducted by the Music Children Foundation.
tutoring classesBehavioural
They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In addition to medical follow-up, the subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation. Qualified orchestral performers will provide the musical training. Training will start at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song). The subjects will continue on to the next level if they successfully pass the relevant test; those who do not will be encouraged to repeat test. Receives: Behavioral: musical training |
| Placebo Control group | Placebo comparator | The subjects will receive medical follow-up according to the schedule of the oncology units.
They will receive the same amount of time and attention as those in the experimental group but not in a way designed to have any specific effect on the outcome measures. They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks). Receives: Behavioral: tutoring classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group
Subjects' IQ scores will be obtained at 12 months after starting the intervention using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older.
In addition, the neuropsychological profile of each subject will also be examined at 12 months after starting the intervention. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.
Measured: 12 month follow-up
Secondary outcomes (7)
neurocognitive function at baseline between intervention and control group
Subjects' IQ scores will be obtained at baseline using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older.
In addition, the neuropsychological profile of each subject will also be examined at baseline. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.
Measured: baseline
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 designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem. Participants will be asked to respond to the Chinese version of the RSES at baseline.
Measured: baseline
Change in self-esteem from baseline at 6 month follow-up between intervention and control group
The subjects' self-esteem will be assessed at 6 months after starting the intervention, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).
The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem.Participants will be asked to respond to the Chinese version of the RSES at 6 months after starting the intervention.
Measured: 6 month follow-up
Change in self-esteem from baseline at 12 month follow-up between intervention and control group
The subjects' self-esteem will be assessed at 12 months after starting the intervention, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).
The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem.Participants will be asked to respond to the Chinese version of the RSES at 12 months 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 healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life.Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at baseline.
Measured: baseline
Change in quality of life from baseline at 6 month follow-up between intervention and control group
The subjects' quality of life will be assessed at 6 months 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 healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life. Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at 6 months after starting the intervention.
Measured: 6 month follow-up
Change in quality of life from baseline at 12 month follow-up between intervention and control group
The subjects' quality of life will be assessed at 12 months 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 healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life. Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at 12 months 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 posted28 Apr 2016 (estimated)
- Study startJan 2016
- 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
- NCT02754908
- Sponsor's protocol ID
- UW16-023
- Status last verified
- Feb 2019
- First submitted
- 26 Apr 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Musical Training in the Improvement of the Neurocognitive Function and Psychological Well-being of Children Surviving Brain Tumours
- ClinicalTrials.gov ID
- NCT02754908
- Acronym / sponsor ID
- UW16-023
- 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
- Jan 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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 examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.
Detailed description
Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.
Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.
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 trainingIn addition to medical follow-up, the subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation. Qualified orchestral performers will provide the musical training. Training will start at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song). The subjects will continue on to the next level if they successfully pass the relevant test; those who do not will be encouraged to repeat test. |
| Placebo Control group | Placebo comparator | Behavioral: tutoring classesThe subjects will receive medical follow-up according to the schedule of the oncology units. They will receive the same amount of time and attention as those in the experimental group but not in a way designed to have any specific effect on the outcome measures. They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks). |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- surviving germ cell tumours of the brain
- be aged from 7 to 19 years
- be able to speak Cantonese and read Chinese
- have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
- have completed treatment for at least two months
Key exclusion criteria (2 listed)
- have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
- with evidence of cancer recurrence or second malignancy in their medical records
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 one year (52 weeks), conducted by the Music Children Foundation. | Behavioural | Experimental group |
| tutoring classesThey will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks). | Behavioural | Placebo Control group |
Primary outcome
Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group
Time frame: 12 month follow-up
Subjects' IQ scores will be obtained at 12 months after starting the intervention using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older. In addition, the neuropsychological profile of each subject will also be examined at 12 months after starting the intervention. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.
7 secondary outcomes
neurocognitive function at baseline between intervention and control group
Time frame: baseline
self-esteem at baseline between intervention and control group
Time frame: baseline
Change in self-esteem from baseline at 6 month follow-up between intervention and control group
Time frame: 6 month follow-up
Change in self-esteem from baseline at 12 month follow-up 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 from baseline at 6 month follow-up between intervention and control group
Time frame: 6 month follow-up
Change in quality of life from baseline 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 28 Feb 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 and tutoring classes 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 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. Some participants in this study may receive a placebo. 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 neurocognitive function 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 28 Feb 2019.