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

NCT05748210 | Recruiting DMC

• 1 other identifier: PAED-2022-010
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Oncology; Survivorship

Keywords

symptom management; cancer; children; caregiver; mobile health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity of child's symptoms

  1 and 2 months after starting the intervention

• Caregivers' quality of life

  1, 2 and 3 months after starting the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Symptom management mobile health application with personalised support

Wait-list control group

ACTIVE COMPARATOR

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.

Other: Wait-list Symptom management mobile health application with personalised support

Interventions

Symptom management mobile health application with personalised support OTHER

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.

Intervention group

Wait-list Symptom management mobile health application with personalised support OTHER

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.

Wait-list control group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

NOT YET RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ankie Tan Cheung, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankie Tan Cheung, PhD

CONTACT

852 3943 0515; ankiecheung@cuhk.edu.hk

William Ho Cheung Li, PhD

CONTACT

852 3943 0889; williamli@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 28, 2023
• Study Start: January 2, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)