Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875. Retrospectively Registered 16 August 2021.

Background Symptom management is a cornerstone of quality care and has the potential to vastly influence patient experiences. The supportive care needs of children, however, are not well described. Objective The aims of this study were to describe documentation about assessment and occurrence of symptoms in medical records of children with cancer and to compare the profile of documented symptoms with child self-report. Methods Twelve weeks of medical records of children (8–18 years) newly diagnosed with cancer were reviewed, and data were extracted regarding symptom assessment and occurrence. A second cohort of children attending oncology outpatients completed the electronic Symptom Screening in Pediatrics self-report of symptom bother. They also answered additional questions about other symptoms and the experience of self-report. We evaluated the profile of symptoms recorded as assessed by healthcare providers and self-reported by children. Results One thousand three hundred sixteen symptoms were identified in 3642 assessments. The symptoms most commonly documented by medical and nursing staff were nausea, pain, and appetite. Allied health staff most frequently documented fatigue, feeling scared, or sad. Forty-eight children completed self-report for the same symptoms and identified fatigue, appetite, and taste were the most bothersome. Children were positive about the experience of completing self-report. Conclusion This study adds further to the evidence about the importance of obtaining information beyond routine clinical assessment from children themselves. Implications for Practice Healthcare providers do not routinely identify all distressing symptoms during clinical encounters. Use of patient-reported outcome measures in children is feasible and acceptable and empowers children to communicate about symptoms, which can facilitate prompt intervention.