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

NCT06015009 | Completed DMC

• 1 other identifier: 2022.461
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncology; Survivorship

Keywords

symptom management; cancer; children; caregiver; mobile health

Outcome Measures

Primary Outcomes (6)

• Feasibility of the intervention

  Feasibility in terms of (1) the recruitment rate

  Upon completion of the intervention (3 months)

• Feasibility of the intervention

  Feasibility in terms of (2) response rate

  Upon completion of the intervention (3 months)

• Feasibility of the intervention

  Feasibility in terms of (3) intervention engagement time and adherence

  Upon completion of the intervention (3 months)

• Feasibility of the intervention

  Feasibility in terms of (4) retention rate of the study

  Upon completion of the intervention (3 months)

• 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)

• 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 Outcomes (2)

• Severity of child's symptoms

  3 months after starting the intervention

• Caregivers' quality of life

  3 months after starting the intervention

Study Arms (1)

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

Interventions

Symptom management mobile health application with personalised support OTHER

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.

Intervention 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 (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ankie Tan Cheung, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: August 17, 2023
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)