Incorporating Patient-Reported Outcomes in Oncology Research With Elaine Novakovich MSN, RN, and Theresa Yu, MSN, RN, OCN®

At this year’s Oncology Nursing Society (ONS) Congress, Elaine Novakovich, MSN, RN, and Theresa Yu, MSN, RN, OCN®, two Research Nurses from the National Cancer Institute, sat down to discuss their presentation about developing An Educational Approach to Support Clinical Trial Nurses to Incorporate Patient-Reported Outcomes (PROs) in Cancer Clinical Trials. In this interview, Ms. Novakovich and Ms. Yu explore what PROs are and how they are used in clinical trials, challenges faced with implementing PROs into clinical trials, the educational plan their team has designed to facilitate the process for clinical trial nurses, and more!

Oncology Data Advisor: Welcome to Oncology Data Advisor. Today we’re here at the Oncology Nursing Society Congress in Washington DC, and I’m joined by Elaine Novakovich and Theresa Yu. Thank you both so much for coming on today.

Elaine Novakovich, MSN, RN: Hello, my name is Elaine Novakovich. I’m a Research Nurse Educator. I work for the National Cancer Institute in the new Office of Patient-Centered Outcomes Research (OPCORe), and my co-presenter—

Theresa Yu, MSN, RN, OCN®: Hi, my name is Theresa Yu. I am the Research Nurse Program Developer working in the same office with Elaine. Thank you.

Oncology Data Advisor: Awesome, I’m looking forward to talking with you both. Today, we’re talking about your presentation here: An Educational Approach to Support Clinical Trial Nurses to Incorporate Patient-Reported Outcomes in Cancer Clinical Trials. For a little bit of background about this, what are patient-reported outcomes, or PROs, and how are they used in clinical trials?

Ms. Novakovich: Thank you. Patient-reported outcomes are an important type of clinical outcomes assessment—collecting information directly from our patients about what is important to them, how they are impacted by both their disease and its treatment, and the value of incorporating PROs into cancer trials. They are recognized by regulators such as the FDA, clinicians, patients, and advocacy groups, because it enhances understanding of the clinical benefit and tolerability of newer cancer therapies. Bringing the voice of our patients into clinical research and including their perspective allows for a broader understanding of the overall impact of newer treatments on our patients and is an emerging important topic in the research environment.

Oncology Data Advisor: What are some of the challenges in integrating PROs into clinical trials?

Ms. Novakovich: We have busy research teams and patients with cancer who are struggling with their disease and prognosis along with their treatment, and we are asking them, all of them, to add yet one more thing to their busy schedules. So, our focus has been on balancing the benefit of understanding the patient’s perspective with the burden of asking too many questions. Our team includes an amazing psychometrician, Dr. Mendoza, who has worked with many others to develop and test many of the current standard PROs that we use.

Oncology Data Advisor: What approach are you taking towards educating clinical trial nurses about PROs, and what does this educational plan involve?

Ms. Novakovich: Thank you, because this question is a natural continuation of the prior question. Because these teams are so busy, we have put a lot of thought and work into a streamlined approach to both the educational component and the actual gathering of the PROs by the research teams in order to encourage buy-in and support of the utilization of the PROs into their trials. So, through early education and support throughout the process, they will become comfortable and in turn incorporate this valuable process into their task flow.

We begin our process early as their trials are being approved, but prior to activation, we reach out to the clinical trial nurse and their team to start educating them on what PROs have been included into their study, what they measure, the expected patient completion time, and when the PROs should be collected throughout their trial. We also remain with the teams throughout their study, including being present in clinic during the consenting process, helping to track PRO completion, and of course continuing to educate them on translating the patient symptom reports that are seen through the data visualization platform that we developed, and can be viewed in real-time and tracked throughout the study.

Oncology Data Advisor: How has the plan been working so far, and how are you planning to evaluate its effectiveness?

Ms. Yu: The plan has been going great because we started our education to our clinical trial nurses early. It supports their understanding of the process and allows for them to be comfortable by the time the trial opens. We are currently planning an evaluation tool to assess the understanding, ease of use, and need for modifications of our program. Importantly, we continue to support and teach research teams throughout their studies so the collection of PROs will become second nature and remain an important part of their studies.

Oncology Data Advisor: How are you hoping that this work will facilitate use of PROs in clinical trials in the future? What are your long-term goals for it?

Ms. Yu: Through developing a systemized process, we hope to increase and optimize the use of PROs in clinical trials. We hope that it’ll make it easier for research teams to utilize and include PROs in their studies. The more we use PROs and get the patient’s voice, hearing how they are impacted by new treatments, it’ll help move research forward use of the standardized PROs template, which we developed and encouraged the teams to use. The hope and goal would be to collect and compare data across studies. With increase of comparable data, we’ll be able to better understand the patient’s perspective and how they are impacted.

Oncology Data Advisor: Just a little more of a broader question, but since the theme of ONS this year is Ignite the Extraordinary, how does this project and the use of PROs overall help to achieve this theme?

Ms. Novakovich: Ignite the Extraordinary. Well, as you can probably detect, we are quite passionate about this topic and its importance in integrating into the research platform. While PROs are an emerging topic, and as mentioned earlier, are valued throughout the current research environment, our program has been thoughtful in supporting early education. It is a streamlined approach with a platform developed to allow teams to observe symptom reports in real time, to track longitudinally throughout their studies and watch for emerging treatment toxicities, and to follow up with important symptom management discussions. So, our program supports both the resource teams and our patients equally.

Oncology Data Advisor: Absolutely. Anything else you’d like to share about the study for anyone who’s interested in learning more?

Ms. Yu: Yes, we are very excited to be part of this new program. Our team has only been working together for two years under the visionary leadership of Dr. Terri Armstrong. A lot of development and a lot of work has happened behind the scenes in order to officially launch our program, and we are now working with several early-phase trials with our OPCORe PROs embedded in their studies. While we were initially met with trepidation to add one more task to the clinical trial nurses’ and team’s responsibilities, we’re happy to share that the response and support have been strong, as they have learned the value of asking patients what matters to them, and patients are opening up and sharing. We have had wonderful feedback from the research teams. We are excited to continue to develop this program and hope one day this will be the norm in all early-phase trials.

Oncology Data Advisor: Wonderful. Well, thank you both so much for stopping by today to tell us about this program. It’s wonderful to hear about and I look forward to hearing more about it in the future.

Ms. Novakovich: Theresa and I both would like to thank you for the opportunity to share this new and important program on your platform. Thank you.

About Ms. Novakovich and Ms. Yu

Elaine Novakovich, MS, BSN, RN, is a Senior Research Nurse Specialist and Educator at the National Cancer Institute and National Institutes of Health. She has been a Research Nurse for over 35 years. Currently, she is working on developing and implementing an educational plan for patient-reported outcomes into clinical trials. Ms. Novakovich joined the OPCORe in October 2022.

Theresa Yu, MSN, RN, OCN®, is a Research Nurse Program Analyst and Developer at the National Cancer Institute and the National Institute of Health. Ms. Yu has been an Oncology RN and Research RN for over 15 years. She joined the OPCORe in October 2022.

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