Oncology Clinical Trial
Official title:
Feasibility, Acceptability, and Effect of a Symptom Management mHealth Application With Personalised Support for Children at the Early Stage of Cancer Survivorship and Their Caregivers: Pre-post Pilot Study
Verified date | April 2024 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot trial aims to determine the feasibility, usability, acceptability, and preliminary effect of the symptom management mHealth app. Participants meeting the aforementioned criteria (section d(i)) will be eligible to participate.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility | Inclusion Criteria: Chinese paediatric cancer survivors will be included if they - are aged 9 to 16 years, - are able to read Chinese and communicate in Chinese, - have completed active cancer treatment (within the previous 2 years), as early symptom management support is crucial to reduce the symptom burden in survivors and their caregivers throughout their survivorship, and - have a smartphone or tablet and are willing to install the mHealth app. The primary caregiver of the paediatric cancer survivors (either the mother or father) - are able to read Chinese and communicate in Chinese, and - have a smartphone or tablet and are willing to install the mHealth app with their children surviving cancer Exclusion Criteria: Chinese paediatric cancer survivors will be excluded if they - have cognitive impairments or psychiatric illnesses - are currently participating in other symptom management studies, or - have evidence of secondary malignancy or recurrence The primary caregivers of the paediatric cancer survivors (either the mother or father) will be excluded if they have cognitive impairments or psychiatric illnesses. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of the intervention | Feasibility in terms of (1) the recruitment rate | Upon completion of the intervention (3 months) | |
Primary | Feasibility of the intervention | Feasibility in terms of (2) response rate | Upon completion of the intervention (3 months) | |
Primary | Feasibility of the intervention | Feasibility in terms of (3) intervention engagement time and adherence | Upon completion of the intervention (3 months) | |
Primary | Feasibility of the intervention | Feasibility in terms of (4) retention rate of the study | Upon completion of the intervention (3 months) | |
Primary | Acceptability of the intervention | Acceptability will be measured using a modified version of the Acceptability E-Scale (AES), a valid and reliable six-item 5-point Likert scale evaluating the acceptability of electronic self-report assessment for oncology population. | Upon completion of the intervention (3 months) | |
Primary | Acceptability of the intervention | Individual, semi-structured interviews will also be conducted to determine the acceptability of the intervention from participants' perspectives. | Upon completion of the intervention (3 months) | |
Secondary | Severity of child's symptoms | The Chinese version of the Patient-Reported Outcomes Measurement Information System® (PROMIS-25) Pediatric-25 Profile version 2.0 is a comprehensive measure document child reports of their symptoms and functioning over the previous seven days. It comprises 24 questions and a single item on pain intensity to evaluate six domains, including physical function, anxiety, depressive symptoms, fatigue, peer relationship, and pain interference. Each domain has Each item has a 5-point Likert scale ranging from ''never'' to ''almost always'' in most domains and from ''with no trouble'' to ''not able to do'' for the physical functioning domain. Higher scores indicate more of the measured symptom being experienced, which signifies worse functioning for anxiety, depression, fatigue, and pain interference, and better physical functioning, and peer relationships. | 3 months after starting the intervention | |
Secondary | Caregivers' quality of life | Primary caregivers' quality of life will be assessed using the Chinese version of the World Health Organization's Quality of Life Instrument at baseline and 3 months after starting the intervention. It is a generic health status measure in assessing the overall QoL and general health (2 items), physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items) using a five-point Likert scale. The item scores were added to calculate the domain scores, where a higher score indicates better quality of life. | 3 months after starting the intervention |
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