Clinical trial NCT06052904: Music Breathing for Caregivers of Children Newly Diagnosed With Cancer
Official title: mHealth-delivered Music Breathing Therapy to Enhance Resilience and Improve Quality of Life of Caregivers of Children Newly Diagnosed With Cancer: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology
Psychological Distress
Keywords: Music breathing
Cancer
Caregivers
Children
Psychological distress
Resilience
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.

Aims:

* To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
* To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.

Hypotheses:

It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Resilience
timeFrame: 2-month after baseline (immediately after the intervention)
measure: Resilience
timeFrame: 6-month after baseline
Secondary outcomes:
measure: Psychological distress (i.e., depression, anxiety and stress)
timeFrame: 2-month and 6-month after baseline
measure: Caregiver strain
timeFrame: 2-month and 6-month after baseline
measure: Coping response
timeFrame: 2-month and 6-month after baseline
measure: Caregiver's quality of life
timeFrame: 2-month and 6-month after baseline
measure: Feasibility outcomes - recruitment rate
timeFrame: Change from recruitment to 6-month follow-up
measure: Feasibility outcomes - intervention engagement/adherence rate
timeFrame: Change from recruitment to 6-month follow-up
measure: Feasibility outcomes - Retention rate
timeFrame: Change from recruitment to 6-month follow-up
measure: Acceptability - Satisfaction
timeFrame: 2-month follow-up (immediately after intervention)
measure: Acceptability
timeFrame: 2-month follow-up (immediately after intervention)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Ankie Tan Cheung
role: PRINCIPAL_INVESTIGATOR
References: