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RECRUITING
NCT05748210
NA

A Symptom Management Application for Children at the Early Stage of Cancer Survivorship and Their Caregivers

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled trial is to examine the efficacy of the mHealth app in improving symptoms experienced by children in the early stage of cancer survivorship, including physical function, anxiety, depressive symptoms, fatigue, peer relationships, and pain interference, and at improving the quality of life (QoL) of the children's primary caregivers The main question it aims to answer is whether survivors who receive the symptom management mHealth app intervention will report improved symptoms, i.e., improved physical function; lower levels of anxiety, depressive symptoms, and fatigue; better peer relationships; and lower pain interference 3 months after starting the intervention. Additionally, we hypothesized that the primary caregivers (either the mother or father) would report an improved QoL 3 months after starting the intervention. Participants in the intervention group will use the mHealth app for 12 weeks with personalised nurse support via interactive communication technologies. They are required to complete questionnaires at baseline (during medical follow-up), 1, 2, and 3 months (via electronic-based systems in the mobile app) Besides, semi-structured interviews and will be conducted to examine the usability, feasibility, and acceptability of the intervention.

Official title: Development and Evaluation of a Symptom Management Mobile Health Application With Personalised Support for Children at the Early Stage of Cancer Survivorship and Their Caregivers

Key Details

Gender

All

Age Range

9 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-01-02

Completion Date

2025-11-30

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

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.

OTHER

Wait-list Symptom management mobile health application with personalised support

To ensure the equity of access to a potentially desirable and effective intervention (i.e., mHeath app for symptom management), participants in the wait-list control group will be invited to receive the same intervention as participants in the intervention group after the completion of all assessments on a voluntary basis.

Locations (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

The Chinese University of Hong Kong

Hong Kong, Hong Kong