Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

NCT06052904 | Completed DMC

• 1 other identifier: PAED-2022-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.

Conditions

Oncology; Psychological Distress

Keywords

Music breathing; Cancer; Caregivers; Children; Psychological distress; Resilience

Outcome Measures

Primary Outcomes (2)

• Resilience

  The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates higher level of resilience.

  2-month after baseline (immediately after the intervention)

• Resilience

  The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates a higher level of resilience.

  6-month after baseline

Secondary Outcomes (9)

• Psychological distress (i.e., depression, anxiety and stress)

  2-month and 6-month after baseline

• Caregiver strain

  2-month and 6-month after baseline

• Coping response

  2-month and 6-month after baseline

• Caregiver's quality of life

  2-month and 6-month after baseline

• Feasibility outcomes - recruitment rate

  Change from recruitment to 6-month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, an online video conferencing platform, by a qualified music therapist.

Behavioral: mHealth-delivered music breathing therapy

Control group

ACTIVE COMPARATOR

Eight weekly online educational modules on medical information and advice about caring for a child who has been newly diagnosed with cancer via email for 2 months.

Behavioral: Online educational modules

Interventions

mHealth-delivered music breathing therapy BEHAVIORAL

Parental caregivers in the intervention group will receive individual home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, by a qualified music therapist based on a standardized and validated music breathing instruction manual. The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing". In each session, participants will practice breathing for approximately 20-25 minutes in silence or with music in a sitting position. Thereafter, the participants will be instructed to create a Mandala drawing to visualize the effects of breathing on their mental body image, emotions, and thoughts. Each session will end with a debriefing session, which will serve to verbally integrate and reflect the participants' experiences and mental states.

Intervention group

Online educational modules BEHAVIORAL

Participants in the control group will receive eight weekly online educational modules via email for 2 months. The content of the online educational modules will include medical information and advice about caring for a child who has been newly diagnosed with cancer.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parental caregivers (the primary caregiver; either mother or father) who
• has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
• can read and communicate in Chinese (Cantonese or Mandarin)
• has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
• is willing to download and use Zoom as the intervention delivery platform.

You may not qualify if:

• has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
• is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
• is currently participating in any interventions or additional counselling services.
• has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ankie Tan Cheung

  Chinese 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: October 3, 2023
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)