Abstract Background Pediatric oncology clinical trials are increasingly complex, requiring rigorous protocol adherence, intensive monitoring, and coordination between clinical and research teams. Bedside nurses are central to trial execution; however, support is often informal and fragmented, increasing the risk of workflow inefficiencies and protocol deviations. These gaps highlight the need for structured, nursing-led models that integrate research expertise into clinical practice. Methods A cross-sectional quality improvement survey was administered to pediatric oncology staff nurses and Clinical Nurse Coordinators (CNCs) in inpatient and outpatient clinical trial care. Domains assessed confidence with trial tasks, protocol access and use, communication pathways, barriers, and educational needs. Quantitative data were analyzed descriptively, and qualitative responses underwent thematic analysis to inform a workflow-integrated, nursing-led support model. Results Participants represented diverse experience; 46% of nurses had 5 years in pediatric oncology, and 67% primarily practiced outpatient. Confidence was higher for trial purpose (56%) and investigational agent administration (68%), but low to neutral for operational tasks, including locating protocol information (55%), recognizing/reporting adverse events or deviations (56%), patient/family communication (57%), and documentation (45%). Protocol use was inconsistent: 34% referenced protocols frequently, and 59% were unaware of existing RN education sheets. Barriers included time/workload (70%), protocol complexity (66%), limited education (57%), restricted access (49%), and unclear points of contact (43%). CNCs reported higher protocol confidence (82%) but significant workload barriers (82%), and only 54% felt prepared to answer staff questions. Conclusion This nursing-led QI initiative identified modifiable system gaps affecting trial execution. An adaptable, hybrid research support model was developed to embed protocol expertise into nursing workflows via standardized tools, defined roles, and real-time support. This approach has potential to enhance patient safety, reduce protocol deviations, and improve trial efficiency. Follow-up evaluation at 3–6 months will assess impact on nursing confidence and clinical trial outcomes.
McHugh et al. (Tue,) studied this question.
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