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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
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.
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.
The Chinese University of Hong Kong
Hong Kong, Hong Kong
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.
Time frame: 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.
Time frame: 6-month after baseline
Psychological distress (i.e., depression, anxiety and stress)
The Chinese version of the 21-item Depression Anxiety Stress Scale will be used to measure caregivers' mental health states of depression, anxiety, and stress over the past week. It is a set of three self-report scales, each of which comprises 7 items, rated on a 4-point Likert scale from 0 (did not apply at all over the last week) to 3 (applied very much or most of the time); a higher total score indicates a greater level of depression, anxiety and/or stress.
Time frame: 2-month and 6-month after baseline
Caregiver strain
The Chinese version of the Modified Caregivers Strain Index will be used to assess the caregiver strain of the participants. Items rated on a 3-point Likert scale (0=no, 1=yes, sometimes, and 2=yes, always); a higher total score indicates a higher level of strain experienced by the caregiver.
Time frame: 2-month and 6-month after baseline
Coping response
The Chinese version of the Brief Coping Orientation to Problems Experienced Inventory will be used to evaluate the coping responses of the parental caregivers. Items rated on a 4-point Likert scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot); a higher total score indicates a greater utilization of that specific type of coping strategy.
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Time frame: 2-month and 6-month after baseline
Caregiver's quality of life
World Health Organization Quality-of-Life Scale will be used to evaluate the quality of life of caregivers. Items are rated on a 5-point Likert scale from 1 to 5; a higher total score indicates a higher quality of life.
Time frame: 2-month and 6-month after baseline
Feasibility outcomes - recruitment rate
Recruitment rates will be calculated as the number of participants who consented to participate in the study divided by the number of participants who meet the inclusion criteria.
Time frame: Change from recruitment to 6-month follow-up
Feasibility outcomes - intervention engagement/adherence rate
Intervention engagement/adherence will be calculated as the number of participants who have completed the music breathing sessions and follow-up sessions, as well as spending at least once daily in performing self-practice music breathing throughout the 2-month intervention period, divided by the number of intervention group participants who have completed the study.
Time frame: Change from recruitment to 6-month follow-up
Feasibility outcomes - Retention rate
Retention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.
Time frame: Change from recruitment to 6-month follow-up
Acceptability - Satisfaction
Caregivers' perceived satisfaction will be assessed using an 12-item investigator-designed satisfaction survey, a higher total score indicates a higher level of satisfaction.
Time frame: 2-month follow-up (immediately after intervention)
Acceptability
A semi-structured individual interview will be used to explore participants' perceptions and experiences of the intervention.
Time frame: 2-month follow-up (immediately after intervention)