KEY TAKEAWAYS
- The phase 2 & 3 trial aimed to investigate the impact of research nurse availability on quality management and study integrity in multi-site cancer research trials conducted by the NCTN.
- Researchers noticed the vital role of dedicated research nurses’ communication in maintaining high-quality research outcomes across multiple NCTN sites; further investigation is ongoing.
National Clinical Trials Networks (NCTN), supported by the National Cancer Institute (NCI), rely on research nurse engagement within multidisciplinary teams to facilitate the development and execution of multi-site colorectal cancer research trials.
However, the demands of competing work obligations often hinder research nurses’ ability to provide timely and detailed support to multi-site study staff. This includes addressing inquiries regarding trial design, study eligibility, adverse events, and data collection/management procedures, as well as initiating quality management-related actions. Consequently, inadequate attention to quality management by overcommitted research nurses can compromise the fidelity and internal validity of research studies within the NCTN framework.
Mary Scott and the team aimed to assess the implications of research nurse availability and engagement on the quality management processes and overall integrity of multi-site cancer research trials conducted through NCTN.
They performed an inclusive analysis of the parent R01-funded study (A221805), incorporating a dedicated advanced practice oncology nurse as the research nurse. The current qualitative study retrospectively analyzed email communications between the research nurse and multi-site research staff who enrolled or intended to enroll patients on A221805. Emails underwent thematic analysis to identify communication patterns.
Initial codes were informed by a theoretical framework and validated by member-checking. Through iterative team meetings, emerging codes and themes were discussed, leading to the inductive refinement of a codebook. The dedicated research nurse provided simultaneous member-checking for qualitative credibility. Dedoose version 9.0.90 facilitated analysis.
About 3 distinct themes emerged from the research nurse’s email communication: educational, validating, and caring. Communication patterns from site staff encompassed questions, gratitude expressions, and prompt, helpful, and/or thorough responses. Codes were linked to outcomes (e.g., research staff knowledge, patient safety, research fidelity) identified in the adapted Quality Caring Model.
The study concluded that the communication of a dedicated research nurse across multiple NCTN sites holds critical importance in ensuring high-quality research outcomes. Further quantitative research is deemed necessary to delve into causal relationships.
The trial was sponsored by the Alliance for Clinical Trials in Oncology.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15495
Clinical Trial: https://clinicaltrials.gov/study/NCT04137107
Scott M, Cho Y, Wilson C, et al. (2024). “Exploring the Role of a Dedicated Research Nurse in a National Cancer Institute Community Oncology Research Program (NCORP) Alliance Study.” Presented at ONS 2024 (Abstract RS158).
