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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05202925
Other study ID # HKCH-REC-2021-008
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We aim to conduct a feasibility study to determine the feasibility and suitability of implementing a musical training program for children surviving brain tumours. This study will demonstrate the feasibility of implementing a musical training program in improving the neurocognitive functioning of surviving brain tumours.


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: 1. To ascertain the feasibility of recruitment and data collection in the outpatient clinic of the Hong Kong Children's Hospital; 2. To assess the response and retention rates of the study; 3. To examine the content of the proposed musical training program for its appropriateness, comprehensiveness and duration to the target participants; 4. 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 5. To assess any changes in neurocognitive functioning of children surviving brain tumours after receiving musical training for 52 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 1, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 16 Years
Eligibility Inclusion Criteria: 1. children who have completed cancer treatment at least 2 months previously; 2. aged between 7 and 16 years, 3. able to speak Cantonese and read Chinese, and 4. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Musical Training Program
a weekly 45-minute lesson, one-to-one musical training

Locations

Country Name City State
Hong Kong The Hong Kong Children's Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rate of the study the proportion of subjects who are eligible and invited and consent to participate. at baseline before the start of the intervention
Primary Response rate of the study The proportion of subjects who complete the questionnaires and assessments at baseline and 12 months after starting the intervention at baseline and 12 months after starting the intervention
Primary Retention rate of the study The proportion of subjects who complete the whole intervention from baseline to 12 months. at baseline and 12 months after starting the intervention
Secondary Nonverbal intelligence scores of the subject Measured by the Test of Nonverbal Intelligence, 4th edition (TONI-4) at baseline and 12 months after starting the intervention
Secondary Attention scores of the subject Measured by the Digit Span at baseline and 12 months after starting the intervention
Secondary Processing speed scores of the subject Measured by the Children's Color Trails Test (CCTT) at baseline and 12 months after starting the intervention
Secondary Executive functions scores of the subject Measured by the Children's Color Trails Test (CCTT) at baseline and 12 months after starting the intervention
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