Oncology Nurses Lead Clinical Trial Success via Planning and Delegation

In the rapidly evolving landscape of oncology research, the Clinical Trials Research Unit (CTRU) at Mayo Clinic in Phoenix has established a model for success rooted in rigorous preparation and strategic nursing leadership. Christina Klawitter, MSN, RN, OCN, RN Team Lead at the CTRU and a member of The Arizona Clinical Oncology Society (TACOS), emphasized in an interview with Oncology Nursing News that the efficacy of clinical trials often hinges on the "back-end" work performed long before a patient enters the treatment room.

The foundation: Rigorous pre-planning

According to Klawitter, the complexity of modern oncology protocols — which can often exceed 100 pages — necessitates a proactive approach to safety and logistics. The CTRU team engages in comprehensive protocol reviews, often collaborating with principal investigators or research coordinators to ensure every detail of the planned treatment is understood.

This pre-arrival workflow is particularly critical when dealing with novel therapies, where side-effect profiles may not be fully established. "With a lot of our novel therapies, we don't always know what we're going to see, side effect-wise," Klawitter noted. "However, we can try to anticipate as best as we can so we're as prepared as we can."

This preparation extends to operational logistics, including precise staffing calculations to determine the number of nurses and support staff required for each day's patient volume.

Nurses "leading the charge"

While clinical trials are multidisciplinary endeavors, Klawitter identifies oncology nurses as the primary drivers of daily execution. Their responsibilities are exhaustive, encompassing the entire spectrum of patient safety and data integrity. Key nursing functions within the CTRU include:

• Safety Assessments: Conducting physical assessments and reviewing laboratory values to confirm a patient is fit for trial participation.
• Order and Protocol Verification: Reviewing physician orders against the strict requirements of protocols to prevent deviations.
• Investigational Agent Administration: Managing the precise delivery of both intravenous and oral investigational drugs.
• Accountability: Ensuring that every study-specific task is completed and documented, which is essential for the validity of the trial data.

Strategic delegation and the multidisciplinary huddle

A hallmark of the Mayo Clinic CTRU’s success is thoughtful delegation, specifically the partnership between oncology nurses and highly skilled medical assistants (MAs). In this model, MAs — who are licensed to perform technical, time-sensitive tasks such as venipunctures, blood sample collection, and electrocardiograms (EKGs) — act as critical extensions of the care team.

The coordination of these tasks begins with a morning huddle, where the team creates a "big picture idea" of the day’s workflow. Klawitter praised the proactive nature of the MAs, noting that they often anticipate necessary tasks before being asked. This synergy allows the unit to function with high efficiency despite the time-sensitive nature of clinical trial testing.

Preserving the human connection

Perhaps the most significant benefit of this delegated model is that it preserves the oncology nurse's "emotional bandwidth." By offloading technical procedures to MAs, nurses can remain "more in tune with the patient." This allows for the delivery of psychosocial and emotional support, which Klawitter describes as a "hallmark to the cancer world."

"We can jump in for those maybe emotional needs, those psychosocial needs," Klawitter explained, ensuring that the human element of nursing is not sacrificed to the technical demands of research. This balance of meticulous protocol adherence and compassionate care defines the nursing leadership at the CTRU, providing a blueprint for other research units aiming to optimize both data quality and the patient experience.