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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06015009
Other study ID # 2022.461
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date July 30, 2024

Study information

Verified date April 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Symptom management mobile health application with personalised support
Other: Symptom management mobile health application with personalised support Child-caregiver dyads in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. The design of the app will be guided by the theory of unpleasant symptoms. The app will comprise several interactive elements to provide children and their caregivers with real-time symptom management support. Comprehensive educational materials regarding cancer and its treatment side effects, including possible symptoms, functional limitations, and psychological responses, will be provided in the app for the children and their caregivers to gain a thorough understanding of the potential symptom burden that they may experience.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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