A Symptom Management Application for Children at the Early Stage of Cancer Survivorship and Their Caregivers
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
Chinese University of Hong Kong
150 participants
Jan 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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.
Exclusion Criteria5
- 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.
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT05748210