- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05202925
Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours
Feasibility Study of a Musical Training Program in Improving the Neurocognitive Functioning of Children Surviving Brain Tumours
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Brain tumour is the second most common childhood cancer in Hong Kong. Evidence shows that cancer and its treatments have long-term and lasting adverse effects on the neurocognitive functioning of paediatric brain tumour survivors, including the impairment of intellectual development and deficits in attention, working memory, processing speed and executive functions. There has been an increase in the use of musical training to promote the neuro-rehabilitation of patients suffering from stroke and Parkinson's disease, and to improve reading skills and academic achievement in young poor readers, and to enhance children's cognitive development. We conducted a randomized controlled trial (RCT) from 2017 to 2018 to examine the effectiveness of musical training on psychological outcomes and quality of life in Chinese paediatric brain tumour survivors. The results showed that participants who received a weekly 45-min lesson on musical training for 52 weeks (intervention group) reported statistically significant fewer depressive symptoms, higher levels of self-esteem, and better quality of life than those who received placebo intervention (control group) at 12-month demonstrating the effectiveness of musical training intervention. Nevertheless, it is unclear whether musical training can also be used to improve neurocognitive functioning, in particular the attention, processing speed, and executive functions of children surviving brain tumours.
The overall aim of this proposed study will be to assess the feasibility of a musical training program in improving the neurocognitive functioning of children surviving brain tumours. The objectives of this feasibility study are as follows:
- To ascertain the feasibility of recruitment and data collection in the outpatient clinic of the Hong Kong Children's Hospital;
- To assess the response and retention rates of the study;
- To examine the content of the proposed musical training program for its appropriateness, comprehensiveness and duration to the target participants;
- To evaluate the appropriateness and feasibility of using various assessment tools in measuring the intelligence, attention, processing speed and executive functions of the paediatric brain tumour survivors; and
- To assess any changes in neurocognitive functioning of children surviving brain tumours after receiving musical training for 52 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joyce Chung
- Phone Number: +852 27666322
- Email: okjoyce.chung@polyu.edu.hk
Study Locations
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Hong Kong, Hong Kong
- The Hong Kong Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- children who have completed cancer treatment at least 2 months previously;
- aged between 7 and 16 years,
- able to speak Cantonese and read Chinese, and
- those who have not undertaken any musical training following their cancer diagnosis.
Exclusion Criteria:
1. those survivors with evidence of cancer recurrence or second malignancy in their medical records
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Musical Training
All subjects in the intervention group will receive a weekly 45-minute lesson, one-to-one musical training for 52 weeks.
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a weekly 45-minute lesson, one-to-one musical training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate of the study
Time Frame: at baseline before the start of the intervention
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the proportion of subjects who are eligible and invited and consent to participate.
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at baseline before the start of the intervention
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Response rate of the study
Time Frame: at baseline and 12 months after starting the intervention
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The proportion of subjects who complete the questionnaires and assessments at baseline and 12 months after starting the intervention
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at baseline and 12 months after starting the intervention
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Retention rate of the study
Time Frame: at baseline and 12 months after starting the intervention
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The proportion of subjects who complete the whole intervention from baseline to 12 months.
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at baseline and 12 months after starting the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nonverbal intelligence scores of the subject
Time Frame: at baseline and 12 months after starting the intervention
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Measured by the Test of Nonverbal Intelligence, 4th edition (TONI-4)
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at baseline and 12 months after starting the intervention
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Attention scores of the subject
Time Frame: at baseline and 12 months after starting the intervention
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Measured by the Digit Span
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at baseline and 12 months after starting the intervention
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Processing speed scores of the subject
Time Frame: at baseline and 12 months after starting the intervention
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Measured by the Children's Color Trails Test (CCTT)
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at baseline and 12 months after starting the intervention
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Executive functions scores of the subject
Time Frame: at baseline and 12 months after starting the intervention
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Measured by the Children's Color Trails Test (CCTT)
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at baseline and 12 months after starting the intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joyce Chung, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKCH-REC-2021-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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