Clinical trial NCT03399864: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Child
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Depressive symptoms at baseline between intervention and control group
timeFrame: baseline
measure: Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Level of self-esteem at baseline between intervention and control group
timeFrame: baseline
measure: Change in level of self-esteem from baseline at 6-month between intervention and control group
timeFrame: 6-month follow-up
measure: Change in level of self-esteem from baseline at 12-month between intervention and control group
timeFrame: 12-month follow-up
measure: Quality of life at baseline between intervention and control group
timeFrame: baseline
measure: Change in Quality of life at 6-month follow-up between intervention and control group
timeFrame: 6-month follow-up
measure: Change in Quality of life at 12-month follow-up between intervention and control group
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li
role: PRINCIPAL_INVESTIGATOR
References: