Work

Charting New Courses: Enhancing Clinical Research Knowledge and Confidence in Stem Cell Transplant and Cellular Therapy-Specialized Advanced Practice Providers

Year: 2025

Type: article

Abstract: Introduction Hematopoietic cell transplant (HCT) and cellular therapy (CT) is a rapidly evolving clinical area with a high volume of ongoing clinical research . Memorial Sloan Kettering Cancer Center (MSKCC) currently offers approximately 60 actively accruing therapeutic trials in HCT/CT; most are high-complexity due to logistical considerations and clinical toxicities experienced. CT and HCT advanced practice providers (APPs) at MSKCC routinely care for patients receiving investigational treatment; however, there is a significant need for structured APP clinical research education. Objectives This pilot program intended to close the education gap and strengthen APP knowledge and confidence in clinical research by providing formal training to outpatient and inpatient APPs practicing in HCT/CT (n = 23). Methods Participants viewed a 35-minute recorded lecture covering many domains of clinical trials operations including: serious adverse events , adverse events , regulatory considerations, clinical documentation, informed consent , protocol navigation, concomitant medications, and research team roles and responsibilities. The knowledge assessment included ten questions assessing understanding of each domain by incorporating example protocols and mock patients from the HCT/CT patient population, while the confidence survey asked participants to assess their confidence in each domain. Pre-intervention and post-intervention knowledge assessments and confidence surveys were administered before and after viewing the educational module. Paired T-Tests and Wilcoxon Ranked Sum Tests were employed to compare knowledge assessment scores and confidence survey responses, respectively. Results Knowledge scores increased in 9 of 10 measured questions (Figure 1) and confidence across all domains improved (Figure 3). The mean overall post-intervention knowledge assessment scores were 77.4%, a 52.1% improvement from the mean baseline score of 50.9% (p <0.01) (Figure 1). Increase in confidence ratings was significant in nearly all measured domains, excepting serious adverse events (Figure 2). Conclusions The pilot program demonstrated a significant increase in APP knowledge and confidence. Areas of least improvement included protocol navigation and adverse events , though baseline knowledge and confidence were above average in these domains. Limitations included small sample size and lack of instrument construct validity , which may have influenced difficulty of knowledge assessment questions. Future considerations include expanding to the broader oncology APP population at MSKCC. Overall, this pilot highlights an opportunity to strengthen clinical research proficiency in HCT/CT-specialized APPs, potentially improving the quality of clinical care and data collection while advancing the role of the APP as a clinical trial investigator.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.jtct.2025.01.788