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

NCT05748210 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Ankie Tan Cheung, PhD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748210 on ClinicalTrials.gov