Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours
Primary Purpose
Cancer Childhood, Brain Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Musical Training Program
Sponsored by
About this trial
This is an interventional other trial for Cancer Childhood
Eligibility Criteria
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
Sites / Locations
- The Hong Kong Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Musical Training
Arm Description
All subjects in the intervention group will receive a weekly 45-minute lesson, one-to-one musical training for 52 weeks.
Outcomes
Primary Outcome Measures
Recruitment rate of the study
the proportion of subjects who are eligible and invited and consent to participate.
Response rate of the study
The proportion of subjects who complete the questionnaires and assessments at baseline and 12 months after starting the intervention
Retention rate of the study
The proportion of subjects who complete the whole intervention from baseline to 12 months.
Secondary Outcome Measures
Nonverbal intelligence scores of the subject
Measured by the Test of Nonverbal Intelligence, 4th edition (TONI-4)
Attention scores of the subject
Measured by the Digit Span
Processing speed scores of the subject
Measured by the Children's Color Trails Test (CCTT)
Executive functions scores of the subject
Measured by the Children's Color Trails Test (CCTT)
Full Information
NCT ID
NCT05202925
First Posted
January 10, 2022
Last Updated
January 10, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Health and Medical Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT05202925
Brief Title
Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours
Official Title
Feasibility Study of a Musical Training Program in Improving the Neurocognitive Functioning of Children Surviving Brain Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 27, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Health and Medical Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Childhood, Brain Tumor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Musical Training
Arm Type
Experimental
Arm Description
All subjects in the intervention group will receive a weekly 45-minute lesson, one-to-one musical training for 52 weeks.
Intervention Type
Other
Intervention Name(s)
Musical Training Program
Intervention Description
a weekly 45-minute lesson, one-to-one musical training
Primary Outcome Measure Information:
Title
Recruitment rate of the study
Description
the proportion of subjects who are eligible and invited and consent to participate.
Time Frame
at baseline before the start of the intervention
Title
Response rate of the study
Description
The proportion of subjects who complete the questionnaires and assessments at baseline and 12 months after starting the intervention
Time Frame
at baseline and 12 months after starting the intervention
Title
Retention rate of the study
Description
The proportion of subjects who complete the whole intervention from baseline to 12 months.
Time Frame
at baseline and 12 months after starting the intervention
Secondary Outcome Measure Information:
Title
Nonverbal intelligence scores of the subject
Description
Measured by the Test of Nonverbal Intelligence, 4th edition (TONI-4)
Time Frame
at baseline and 12 months after starting the intervention
Title
Attention scores of the subject
Description
Measured by the Digit Span
Time Frame
at baseline and 12 months after starting the intervention
Title
Processing speed scores of the subject
Description
Measured by the Children's Color Trails Test (CCTT)
Time Frame
at baseline and 12 months after starting the intervention
Title
Executive functions scores of the subject
Description
Measured by the Children's Color Trails Test (CCTT)
Time Frame
at baseline and 12 months after starting the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce Chung
Phone
+852 27666322
Email
okjoyce.chung@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Chung
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Children's Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Yuen
Phone
35133193
12. IPD Sharing Statement
Learn more about this trial
Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours
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