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Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

Primary Purpose

Oncology, Psychological Distress

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
mHealth-delivered music breathing therapy
Online educational modules
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncology focused on measuring Music breathing, Cancer, Caregivers, Children, Psychological distress, Resilience

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Acceptability
A semi-structured individual interview will be used to explore participants' perceptions and experiences of the intervention.

Full Information

First Posted
September 13, 2023
Last Updated
October 9, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT06052904
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
April 2, 2025 (Anticipated)
Study Completion Date
April 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Psychological Distress
Keywords
Music breathing, Cancer, Caregivers, Children, Psychological distress, Resilience

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mHealth-delivered music breathing therapy
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Online educational modules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resilience
Description
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)
Title
Resilience
Description
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
Secondary Outcome Measure Information:
Title
Psychological distress (i.e., depression, anxiety and stress)
Description
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
Title
Caregiver strain
Description
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
Title
Coping response
Description
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.
Time Frame
2-month and 6-month after baseline
Title
Caregiver's quality of life
Description
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
Title
Feasibility outcomes - recruitment rate
Description
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
Title
Feasibility outcomes - intervention engagement/adherence rate
Description
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
Title
Feasibility outcomes - Retention rate
Description
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
Title
Acceptability - Satisfaction
Description
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)
Title
Acceptability
Description
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ankie Tan Cheung, PhD
Phone
852 3943 0515
Email
ankiecheung@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ankie Tan Cheung
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankie Tan Cheung, PhD
Phone
852 39430515
Email
ankiecheung@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

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