Effectiveness of Musical Training in Children Surviving Brain Tumours

NCT02754908 | Completed DMC

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

Brief Summary

This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.

Conditions

Brain Neoplasms; Child

Outcome Measures

Primary Outcomes (1)

• Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group

  Subjects' IQ scores will be obtained at 12 months after starting the intervention using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older. In addition, the neuropsychological profile of each subject will also be examined at 12 months after starting the intervention. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.

  12 month follow-up

Secondary Outcomes (7)

• neurocognitive function at baseline between intervention and control group

  baseline

• self-esteem at baseline between intervention and control group

  baseline

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

  6 month follow-up

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

  12 month follow-up

• quality of life at baseline between intervention and control group

  baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

In addition to medical follow-up, the subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation. Qualified orchestral performers will provide the musical training. Training will start at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song). The subjects will continue on to the next level if they successfully pass the relevant test; those who do not will be encouraged to repeat test.

Behavioral: musical training

Placebo Control group

PLACEBO COMPARATOR

The subjects will receive medical follow-up according to the schedule of the oncology units. They will receive the same amount of time and attention as those in the experimental group but not in a way designed to have any specific effect on the outcome measures. They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).

Behavioral: tutoring classes

Interventions

musical training BEHAVIORAL

The subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation.

Experimental group

tutoring classes BEHAVIORAL

They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).

Placebo Control group

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• surviving germ cell tumours of the brain
• be aged from 7 to 19 years
• be able to speak Cantonese and read Chinese
• have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
• have completed treatment for at least two months

You may not qualify if:

• have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
• with evidence of cancer recurrence or second malignancy in their medical records

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: April 26, 2016
• First Posted: April 28, 2016
• Study Start: January 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)