ACORI Research Review: December 2022

Chronic stress and emotional exhaustion render all healthcare providers vulnerable to substantial burnout. In addition to the routine patient care that oncology nurses are responsible for, treatment and monitoring for cancer clinical trials can also fall under the workload of oncology nurses. Research trials have complicated protocols that demand rigorous pharmacokinetic lab draws and monitoring, which can often be missed or inappropriately timed when delegated to infusion nurses who are also taking care of routine treatments. To alleviate some of the burdens experienced by outpatient oncology nurses and to improve the overall quality of research care, one cancer center decided to create a new infusion position specifically focusing on clinical trials. Highlands Oncology Group in Springdale, AR hired its first research infusion coordinator in December 2021 to “provide care to medical oncology patients and follow the subjects enrolled on their clinical trials.”

At Highlands Oncology Group, the research infusion coordinator position is a hybrid role that is responsible for performing duties both as an infusion nurse and as a clinical research coordinator. It sounds busy, but in reality, most of the workload is the infusion portion of the position; the purpose of having the nurse take on a few studies as clinical research coordinator is to keep the nurse active in the research world so that they are familiar with navigating and managing study protocols. According to Highland Oncology Group’s position description, the research infusion coordinator will:

• Screen potential study patients according to protocol criteria
• Meet with study subjects and schedule visits
• Report all adverse events to the principal investigator and sponsor
• Obtain and complete data/records for study subjects and/or work with the research data coordinator
• Work with Investigators, mid-level providers, nurses, and other clinical research coordinators to identify/document toxicity, etc.
• Act as a resource to hospital and clinic personnel regarding research activity
• Provide infusion services to research patients in all phases of trials.

The research infusion coordinator position has been so successful that the practice recently hired its second nurse in this role this past summer. Both nurses came from the ICU (intensive care unit) setting and had plenty of experience with timely lab draws, acute care, and managing infusions. Per the position description, oncology experience is preferred, but not required. According to Helen Holtzen, director of research, and Adam Torres, assistant director of research at Highlands Oncology Group, the learning curve for most will be the research component. “They already know how to be a nurse, [so the focus] should be on building a strong research foundation,” shares Adam. Onboarding for the research infusion coordinators is different from onboarding for a traditional clinical research coordinator, in that the exposure to research is substantially less when onboarding the research infusion coordinator due to the split responsibilities of the role at baseline. For their second research infusion coordinator nurse, a mix of infusion days and shadowing other research staff worked best for the onboarding process.

Since there are only two nurses in this role at Highlands Oncology Group, they manage themselves and decide which patients they want to see. At this time, the practice is running 120 clinical trials with 161 active research patients (63 being treated), averaging about 4 to 7 research infusions/injections per day between 2 nurses. Torres notes that, at this time, the two nurses could even take on a few more studies to further maximize patient volume without becoming overwhelmed.

Their general daily workflow is as follows. Each morning, one nurse sends the research infusion schedule to pharmacy/infusion to update the rest of the team. The two nurses communicate with pharmacy throughout the day via Microsoft Teams to indicate when drugs/patients are ready. Finally, the drug is delivered from pharmacy and administered by the nurse. In addition, the nurses can assist with procedures, such as bone marrow biopsies, and conduct port draws based on specific study requirements, resulting in tubes that are filled properly with enough sample. There are also two medical assistants who work with the research infusion coordinators and can assist with lab draws and monitoring if needed. Both research infusion coordinators have dedicated desks in the chemo suite and give reports to each other throughout the day. At Highlands Oncology Group, the research infusion coordinators see patients Monday through Thursday (8- or 10-hour days) and have “flex Fridays” to catch up on administrative and other tasks.

Overall, the implementation of the research infusion coordinator role has greatly enhanced the quality of care provided to research patients at Highlands Oncology Group. A nurses’ role in caring for a research patient consists of all the usual nursing responsibilities in addition to study-mandated stipulations and procedures. Due to the complexities of clinical trial protocols, study deviations occur frequently, especially in oncology trials where more than 40% of enrolled patients may be affected by protocol deviations, according to a recent analysis. Therefore, having research infusion coordinator nurses who are solely dedicated to learning and following the nuances of a study can significantly help reduce protocol deviations, as evidenced by the recent changes at Highlands Oncology Group.

Moreover, Torres explains that it “helps to have a research face in the infusion clinic outside of the research department; for example, [the research infusion coordinators] can explain why it is a big deal in research to run one minute over infusion.” These minute details, while trivial to most routine care, can be considered significant deviations in research, a concept that may be hard for non-research staff to grasp. Not only do these research-focused nurses help to improve care for study patients, but they can also provide staffing support to the regular infusion clinic if needed, provided that their own research tasks are taken care of.

The infusion nursing team at Highlands Oncology noticed such an improvement in staff morale with the first research infusion coordinator that they donated a regular infusion nurse FTE to the Research Department to hire a second research infusion coordinator. Ultimately, these two positions have led to a reduction in study deviations, improvement in patient as well as study coordinator satisfaction, shorter wait times for study patients, and faster turnaround on study timelines. Holtzen, Torres, and their team at Highlands Oncology Group remark that there have been almost no downsides since start this staffing model. For cancer programs and practices that are currently struggling to manage their research infusions, implementing a similar position may well be worth considering.

The goal of the Biobank is to establish a large archive of biospecimens that researchers can use to study how different tumor types develop over time, as well as how they respond to or become resistant to treatment.

The Biobank partners with community cancer programs and practices to enroll patients onto this study. Currently, there are 97 active trial sites in the Biobank. Once a patient is enrolled, the study coordinator collects patient data along with biospecimens and sends them to the Biorepository, where a multitude of molecular testing is conducted. Data is then collected and shared with scientists and clinicians to advance cancer research.

A significant part of the study process is the digitalization of patient consent, as well as data collection and analysis. To optimize electronic record keeping, the Biobank has partnered with Medidata—a unified, cloud-based platform that addresses the holistic clinical research process from start to finish—to enroll patients and collect data. Medidata has developed a secure and user-friendly electronic consent app which presents informed consent forms and HIPAA documents to the patient for the Biobank study. These documents can be customized for each institution if needed. As part of the consent process, Medidata also provides a video describing the study to the patient. The video emphasizes the importance of the Biobank project and explains why the NCI is collecting a diverse array of biospecimens.

When clinicians qualify a patient for the Biobank study, they will provide the patient with a tablet on which to watch the video, after which the eConsent will be presented. While reviewing the eConsent, patients can flag certain sections for further discussion if needed. Medidata eConsent can also be translated into other languages, as well as printed or downloaded for recordkeeping.

According to Walter Lee, client services director at Medidata Solutions, “eConsent makes it easy for the patient and takes a lot of burden off the patient [and provider].” Not only are consents more convenient for patients, but they also improve efficiency for study personnel and clinicians by cutting out manual data entry and more quickly capturing re-consents for protocol amendments.

In addition to eConsents, Medidata also provides its Rave Electronic Data Capture services to the Biobank study. Rave is a robust data capture and management system used in more than 29,000 clinical trials. Based on the 2020 Industry Standard Research Report (EDC Market Dynamics and Service Provider Performance, 4^th Edition), “Medidata Rave was the runaway first-choice preference for all trial types.” Features of Rave Electronic Data Capture include centralized administration and management of studies and users; elimination of study master data duplication and inconsistencies; real-time data validation; streamlined data review and task overview; and real-time reporting and analytics. In the Biobank study process, Rave is the primary platform for clinical data capture and is also used to generate labels for the packaging and shipping of biospecimens.

As much as the Cancer Moonshot Biobank needs patients, so too does it need the right technology to be able to support its research efforts. David Geismar, senior vice president of Professional Services at Medidata, notes: “Helping enroll patients with eConsent and managing patient data with Rave Electronic Data Capture are important pieces of the overall Cancer Moonshot Biobank effort to accelerate progress in treating cancer and helping patients with cancer live longer.”

A total of 4,756 patients across both cancer centers were identified for the institution-wide cohort. Compared to pre-pandemic times (December 2019 to February 2020), a 46% reduction in newly enrolled patients was seen during the initial peak of the pandemic (March to May 2020). However, clinical trial enrollment bounced back quickly thereafter, with a return to normal levels (and even 2.7% more enrollments) by March to May 20201. Notably, new patient accruals were not impacted during the second peak of the pandemic (December 2020 to February 2021). In the manually-curated cohort, patients who were already on trial pre-pandemic mostly remained on trial during the first pandemic period. However, those who were taken off trial during the first pandemic period were more likely to be non-white compared to white. This is an interesting finding that echoes other reports highlighting racial disparities in care during this time.

When assessing the types of trials that were enrolling new patients, the researchers found that, between pre-pandemic times (December 2019 to February 2020) and several periods within the pandemic, significantly more patients were being enrolled onto industry-sponsored trials compared to academically-sponsored trials for unclear reasons. At Dana Farber, new cancer trials declined by roughly 25% during the first peak but rebounded by March to May 2021 to levels higher than pre-pandemic levels (+30%). During the pandemic, the amount of trial deviations significantly increased compared to pre-pandemic times, although most of the deviations noted were minor. The rate of serious adverse events was not significantly different during the pandemic compared to before the pandemic.

Although it may not be surprising that trial enrollment was drastically impacted by the first peak of the COVD-19 pandemic, it is reassuring to find that accrual has not only returned to pre-pandemic levels but has even exceeded pre-pandemic rates in some cases. Dr. Deborah Doroshow, one of the principal investigators of this study, recalls how heartbreaking it was to see patients during the first peak and not be able to offer them clinical trials. “I felt powerless,” she notes, “[as a Phase I clinician and medical oncologist], my goal is to have a trial for every patient who is referred to me.” Many clinical investigators across the country can likely relate to similar feelings of helplessness. Fortunately, the first wave of the COVID-19 pandemic taught us the importance of having back-up plans and implementing protocols to ensure that medical care does not become compromised. In the setting of increased guidance and greater overall comfort with the virus, clinical trials are thriving once again.