Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 14, 2025
Date Accepted: Dec 19, 2025
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Implementing an eHealth Model of Care for Pediatric Patients and Families at the End-of-Treatment for Acute Lymphoblastic Leukemia (EMERGE): A Type 2 hybrid effectiveness trial study protocol
ABSTRACT
Background:
Despite increasing survival rates for childhood cancers, physical and psychological late effects are common. The end-of-treatment period is recognized as a complex transition period and there are few evidence-based models of care to address patient and family needs during this early survivorship period. The EMERGE model of care has been developed to provide e-health delivered, multidisciplinary care to patients and families in the 12 months following treatment for acute lymphoblastic leukemia (ALL), the most common type of pediatric cancer.
Objective:
The primary aim of this study is to assess the implementation success of the EMERGE model into the clinical setting. Secondary aims include evaluating effectiveness and cost consequences.
Methods:
The study utilises a pragmatic hybrid implementation effectiveness design, assessing both implementation and clinical outcomes. Implementation metrics include evaluating; reach, acceptability, feasibility and maintenance of the EMERGE model. Clinical effectiveness outcomes include parent satisfaction with the EMERGE intervention and pre-post intervention evaluation of parent psychological stress and unmet information needs. The RE-AIM implementation science framework was utilised to guide study outcomes. Semi-structured interviews with clinicians and parents will further evaluate the acceptability and sustainability of the EMERGE model and appraise barriers and facilitators to implementation. Cost analysis will include evaluation of the resources required for program delivery and the impact on subsequent healthcare service use measured using Medicare data and health service utilization collected during the EMERGE intervention.
Results:
Trial commenced in December 2022, and recruitment concluded in October 2025. Data collection is ongoing and is anticipated to be completed in 2026
Conclusions:
This study will address a critical gap in multidisciplinary care delivery at end-of-treatment for young survivors of ALL and their families. The EMERGE model has the potential to improve the quality of life of patients and families by providing an early survivorship intervention. Importantly the utilization of an e-health (telehealth) model will enable distance-delivered care, facilitating family participation regardless of geography. By measuring implementation, clinical and cost impacts, this study will inform the future development of end-of-treatment models of care that are almost universally lacking in pediatric oncology care. Clinical Trial: Australian New Zealand Clinical Trials Registry U1111-1272-5457
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