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

NCT03399864 | Completed DMC

• 1 other identifier: UW16-023_2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Child

Outcome Measures

Primary Outcomes (1)

• 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.

  12-month follow-up

Secondary Outcomes (8)

• Depressive symptoms at baseline between intervention and control group

  baseline

• Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group

  6-month follow-up

• Level of self-esteem at baseline between intervention and control group

  baseline

• Change in level of self-esteem from baseline at 6-month between intervention and control group

  6-month follow-up

• Change in level of self-esteem from baseline at 12-month between intervention and control group

  12-month follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

OTHER

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

Other: usual care

Interventions

musical training BEHAVIORAL

The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.

Experimental group

usual care OTHER

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

Control group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ho Cheung William Li

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: February 20, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)