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ACORI RESEARCH REVIEW: DECEMBER 2022

The Role of Research Infusion Nurses

Oncology nursing is an inherently stressful job due to the emotional burdens and medical complexities of caring for patients with cancer. Since the outbreak of the pandemic, oncology nurses have only taken on additional responsibilities in patient care. Nursing distress, along with that of all healthcare providers, is at a record high these days, rising from about 50% pre-pandemic to 96% during the pandemic.

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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.

Cancer Moonshot Biobank Gets a Boost from Medidata

In 2016, Vice President Joe Biden launched the Cancer Moonshot Initiative to accelerate the fight against cancer. As President, he has now revitalized the initiative with a goal to reduce cancer deaths by at least 50 percent over the next 25 years and improve the overall experience of patients and families living and surviving with cancer. As part of the Initiative, the National Cancer Institute (NCI) launched the Cancer Moonshot Biobank in 2020 to expedite cancer research progress by creating a repository of tumor samples donated by patients.

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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, 4th 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."

Study Data from Two Large U.S. Cancer Centers Show that Clinical Trials Have Bounced Back after Significant COVID-19 Disruption

A recent study published in the Annals of Oncology revealed that cancer clinical trials have rebounded from the significant disruption during the peak of the pandemic. Researchers at Dana Farber Cancer Institute and the Tisch Cancer Institute of Mount Sinai collaborated in a large prospective study assessing the impact of the pandemic on therapeutic oncology trials at the two academic centers between December 2019 and June 2021. Patients were categorized into two specific cohorts: an institution-wide cohort consisting of all new accruals in the prespecified time period; and a manually curated cohort consisting of patients who had an outpatient medical oncology visit during the week of March 2 to 6, 2020 (index week). For the manually curated cohort, data was captured for the three months before and after the index week.

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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.

Debunking Myths About Diversity in Clinical Trials

Earlier this year, an article was published in Nature Medicine regarding misconceptions about diversity in early-phase clinical trials. Diversity, equity, and inclusion (DEI) are often unaddressed in Phase I trials based on notions that these issues can be addressed in later phase studies. However, such attitudes can be dangerous because Phase I studies provide key safety data, and lack of diversity early on sets the stage for inconsistencies in care, particularly in the era of expedited drug approvals.

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The authors give the example of the accelerated approval of Trodelvy® for metastatic breast cancer: the initial study leading to FDA approval included only 7 percent of Black patients. It was not until a follow-up subgroup analysis of Black patients that researchers confirmed a similar survival benefit for Black women as the overall study population. While it is reassuring that the survival benefit is seen across the board, it would be preferable—both ethically and logistically—to have this information upfront before initial approval of the drug. Another poignant example is the lack of diversity in early-phase Covid-19 vaccine trials. The large majority of patients in Moderna and Oxford vaccine studies were white, and some argue that this aspect, along with a general mistrust of healthcare professionals, may have discouraged underrepresented individuals from receiving the vaccines.

One hesitancy about increasing diversity in Phase I trials is the thought that heterogeneity may complicate interpretation of results. However, to truly understand how a drug works in a real-world setting, the drug must be studied in those who will ultimately use the drug. The authors argue that DEI in research can uncover important variations in drug tolerability or response among certain groups of people that might otherwise be masked if those groups were not included in studies. A prominent example of this is the use of erlotinib in non-small cell lung cancer. Because of the diverse patient population in the initial study, researchers were able to observe that Asian women had a better response to erlotinib, which led to the discovery of the L858R EGFR mutation in this patient population.

Another common misconception is that enhancing diversity in clinical studies will lead to compromised outcomes, since underrepresented patients tend to have worse outcomes overall. This assumption, however, is uninformed and harmful to patients. For instance, analyses indicate that Black patients with colorectal cancer experience higher mortality rates than white patients primarily because of inequalities in access to care, and not because these patients naturally have suboptimal outcomes to treatment. Lastly, financial myths also hinder early inclusion of diverse populations in clinical trials. Industry colleagues may worry that efforts to enhance DEI will reduce returns on investment, but in actuality, early diversification can be a cost-effective strategy for product development. Learning upfront if a drug will work safely and effectively in certain patient populations can curtail costlier later-phase trials or expand early access to important treatments as needed.

The Potential of Decentralized Clinical Trial Technology

Decentralized clinical trials have gained significant traction recently thanks to the pandemic. Investments in decentralized clinical trial technologies are on the rise, with more deals for decentralized clinical trial companies in Q2 of 2022 than previous quarters and $534 million in funding in the last year. Retail companies, such as CVS Health and Walgreens, have also been jumping on the bandwagon of decentralized clinical trials and launching their own clinical trial businesses. Since the launch of its clinical trial division, CVS Health has participated in 20 different COVID-19-related studies within the last year. Josh Rose, the head of CVS's decentralized clinical trials, notes that community-based research is more patient-centric than traditional trials because it is more convenient for patients to participate in and makes it easier for stakeholders to study a more diverse population. Per Rose, "the beauty of both technology and community-based clinical research is [that] you're able to bring in a representation of patients that aligns with the area's true demographics."

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Financially, decentralized clinical trials are estimated to be five times cheaper to run than traditional studies in the Phase II setting, according to research from Tufts University School of Medicine. In the long run, decentralized clinical trials can help speed up drug approvals by allowing clinical trials to be completed more efficiently, meaning that patients can get new treatments faster. One of the main challenges in implementing decentralized clinical trials at this point is fear of change. Rose comments, "I would say that CVS tends to be a very conservative organization because of who we are in the industry and that is not good for speed…Getting people to overcome the traditional mindset has been a little bit of a hurdle." Dr. Jeff Kingsley, CEO of Centricity Research, notes that "it's scary to be the one to take the gamble on decentralized clinical trials." Despite the hesitations, overall utilization of these trials has been increasing, with the research mindset slowly shifting to consider more ways to incorporate decentralized clinical trials alongside traditional clinical trials.

A Spotlight on the Cancer Experience Registry Online Research Study for Patients and Caregivers

The Cancer Experience Registry (CER) is an IRB-approved research study established by the Cancer Support Community's Research and Training Institute. The CER is an observational clinical trial listed on clinicaltrials.gov. CERS' online surveys for patients and caregivers are designed to gain a better understanding of the broad impact of cancer in all areas of life. Initially implemented in 2010, the CER underwent a re-launch in 2021, which updated the surveys and enhanced the overall user experience. Since the re-launch, nearly 2,000 individuals with cancer and 300 caregivers have enrolled in the CER and completed the new 35-minute survey.

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The CER is open to adults in the United States or Canada who have been diagnosed with cancer or who have provided care to a family member, friend, or loved one with cancer. The survey covers an extensive array of questions to gauge the overall emotional, physical, financial, and practical impact of cancer. Participants who complete the initial survey are followed for two years with subsequent shorter surveys that assess changes over time and focus on emerging topics in cancer care. The CER provides cross-sectional, longitudinal, dyadic (pairing patients and their caregivers), and subgroup data.

Key Findings

In 2020, the Research and Training Institute published a report of key survey findings from 2,569 patients and survivors who joined the Registry between January 1, 2016 and June 30, 2019. More than 40 types of cancer were reported by participants; the most common cancers included breast, gynecologic, prostate, and lung cancers. Approximately 40% to 50% of patients were at risk for clinically significant levels of depression and anxiety and 56% were moderately to very seriously concerned about eating and nutrition. Four out of 10 patients felt inadequately prepared to manage the side effects of treatment and 1 out of 3 withheld information from providers about their side effects and symptoms. Seven out of 10 patients reported that no one from the healthcare team discussed the cost of care and 33% depleted savings or used retirement funds to cover treatment costs. Half of the patients either feared receiving a placebo in a clinical trial or were uncomfortable with random assignment of treatment. In terms of shared decision-making, 1 out of 3 patients were not satisfied with their level of participation and 1 in 2 felt unprepared to discuss treatment options. Overall, the results revealed critical opportunities to improve care in patients with cancer.

Real-World Impact

Thus far, CER data have been used to develop distress screening programs for patients and caregivers; to inform educational materials addressing quality of life, financial burden, cancer clinical trials, shared decision-making, and symptom and side-effect management; to support policy recommendations to address inequities in care; and to seek funding for additional support services.

Call to Action

While findings from the CER have informed a variety of program development and policy initiatives, opportunities remain to reach more patients and caregivers, connect with new communities, and capture more diverse voices. A new initiative to partner with cancer programs and practices can help support these goals. In turn, by partnering with the CER, cancer programs and practices can receive data regarding their specific patient population.

To promote the CER, the Research and Training Institute has developed a toolkit with informational flyers and social media postings for cancer programs and practices to use to accrue patients or caregivers. For more information about the CER, please reach out to Heather Badt, Executive Director at the Research and Training Institute: hbadt@cancersupportcommunity.org.