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Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors

Primary Purpose

Brain Neoplasms, Child

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
musical training
usual care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Neoplasms

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • children who have undertaken any musical training following their cancer diagnosis
  • survivors with evidence of recurrence or second malignancies
  • survivors receiving palliative care

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

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.

The subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 8, 2018
Last Updated
June 10, 2019
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03399864
Brief Title
Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Child

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
The subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units.
Intervention Type
Behavioral
Intervention Name(s)
musical training
Intervention Description
The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
The subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units.
Primary Outcome Measure Information:
Title
Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.
Description
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.
Time Frame
12-month follow-up
Secondary Outcome Measure Information:
Title
Depressive symptoms at baseline between intervention and control group
Description
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.
Time Frame
baseline
Title
Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group
Description
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.
Time Frame
6-month follow-up
Title
Level of self-esteem at baseline between intervention and control group
Description
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.
Time Frame
baseline
Title
Change in level of self-esteem from baseline at 6-month between intervention and control group
Description
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.
Time Frame
6-month follow-up
Title
Change in level of self-esteem from baseline at 12-month between intervention and control group
Description
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.
Time Frame
12-month follow-up
Title
Quality of life at baseline between intervention and control group
Description
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.
Time Frame
baseline
Title
Change in Quality of life at 6-month follow-up between intervention and control group
Description
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.
Time Frame
6-month follow-up
Title
Change in Quality of life at 12-month follow-up between intervention and control group
Description
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.
Time Frame
12-month follow-up

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: 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) Exclusion Criteria: children who have undertaken any musical training following their cancer diagnosis survivors with evidence of recurrence or second malignancies survivors receiving palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors

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