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

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ClinicalTrials.gov Identifier: NCT03399864
Recruitment Status : Recruiting
First Posted : January 15, 2018
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Brain Neoplasms Child Behavioral: musical training Other: 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 (Choi, Lee, & Lim, 2008), to improve self-esteem and mood recognition in hospitalized adolescent patients diagnosed with "adjustment reaction to adolescence" (Henderson, 1983), to improve social skills of children with autism (Ghasemtabar, Hosseini, Fayyaz, Arab, Naghashian, & Poudineh,2015), to enhance reading skills and academic achievement in young poor readers (Cogo-Moreira, Brandão de Ávila, Ploubidis, Mari, 2013), and to facilitate children's cognitive development (Wan, & Schlaug,2010). 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental group
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.
Behavioral: musical training
The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.
Control group
The subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units.
Other: usual care
The subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units.


Outcome Measures

Primary Outcome Measures :
  1. Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group. [ Time Frame: 12-month follow-up ]

    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 :
  1. Depressive symptoms at baseline between intervention and control group [ Time Frame: baseline ]

    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.


  2. Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow-up ]

    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.


  3. Level of self-esteem at baseline between intervention and control group [ Time Frame: baseline ]

    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.


  4. Change in level of self-esteem from baseline at 6-month between intervention and control group [ Time Frame: 6-month follow-up ]

    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.


  5. Change in level of self-esteem from baseline at 12-month between intervention and control group [ Time Frame: 12-month follow-up ]

    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.


  6. Quality of life at baseline between intervention and control group [ Time Frame: baseline ]
    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.

  7. Change in Quality of life at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow-up ]
    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.

  8. Change in Quality of life at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow-up ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399864


Contacts
Contact: Ho Cheung William Li 39176634 william3@hku.hk
Contact: Tan Cheung 39176675 tankie@hku.hk

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: Ho Cheung William Ho, PhD    852-39176634    william3@hku.hk   
Principal Investigator: Ho Cheung William Li, PhD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ho Cheung William Li The University of Hong Kong
More Information

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03399864     History of Changes
Other Study ID Numbers: UW16-023_2
First Posted: January 15, 2018    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases