Welcome to Oncology Data Advisor, where we explore the latest advances in cancer research and treatment. I am Selma Khenissi from i3 Health.
In this podcast, Dr. Kelly Brassil, PhD, RN, from The University of Texas MD Anderson Cancer Center, will be discussing patient-reported symptom data and how it affects patient survival and quality of life.
Selma Khenissi, MPS:
Can you comment on how tools such as Project Patient Voice positively impact the outcomes of patients with classical Hodgkin lymphoma?
Dr. Brassil, PhD, RN:
Absolutely. Project Patient Voice, for those who may not be as familiar, is an initiative through the Food and Drug Administration that focuses on the [reporting] of patient-reported outcomes (PRO) measures [from] clinical trials, evaluating new and evolving treatment options. The idea is that we need to know more than just overall survival, that that doesn't tell us the whole story. What we're really looking toward is not only how does the drug impact the survival curve, but how does it impact the lived experience of the individual receiving treatment, in terms of symptom burden and other outcomes that influence quality of life during and following therapy?
Project Patient Voice focuses on [reporting] validated patient-reported outcome measures, as many studies have done in the past, but creating some standards for the sharing and evaluation of the patient-reported outcomes and the inclusion of reports about those outcomes. I think that this particularly benefits patients, because it allows individuals to understand, if they're looking at this type of data, not only how long they might expect to live if they're receiving a particular drug, but also how they might expect to feel. That experience is a big part of the overall cancer care landscape.
Good to know. Thank you. So for those who want to share patient symptom data, how can patients and medical care professionals do so?
That's a really great question. I think one of the big challenges that face the health care community right now is how do we not only integrate PROs in clinical trials where they've already existed for some time, as we've discussed, but how do we also integrate PRO into standard clinical practice, so that once patients are receiving the drug off-trial, we have a similar pattern for consistent tracking. There are many ways to do this. In the context of clinical trials, certainly the patient-reported outcomes become a standard measure. They're collected at a particular point in time and consistently throughout the study.
Then, when we translate that into standard clinical practice, many institutions are adopting this in different ways. Certainly the work of Ethan Basch and his colleagues has been instrumental in transforming our appreciation for the importance of patient-reported outcomes. That has also been picked up in the development of new tools, such as the promise Common Terminology Criteria for Adverse Events (CTCAE), which allows us to mirror some of the clinical trials grading criteria for adverse events, but also to incorporate a tool that assesses patient-reported outcomes in a similar manner.
When we talk about how to collect and integrate these into practice, typically it's done as a scheduled occurrence around particular office visits or follow-up occurrences. These instruments often can be sent through electronic health records or can be completed on tablets during clinic visits. Then for individuals who may not be as technologically savvy, being able to provide perhaps a paper version or alternate versions for individuals is very important. That includes being able to provide validated translated versions of measures for non-English speaking populations, as well as looking at other ways to collect this data. If you have someone with a sensory impairment, for instance, who may be blind or deaf, etc.
Good to know. So who is responsible for reading the data?
This is also a great question. One of the challenges is that as much as we know that patient-reported outcome data is important to collect, and it can be meaningful—again, going back to the work of Dr. Basch and others, we've actually been able to observe in trials evaluating patient-reported outcomes that not only are they associated with improved quality of life, they can actually be associated, if monitored correctly, with improved overall survival, and that's significant. But the challenge is that you suddenly have kind of a fire hose of information. Many of these measures have multiple items. They could be 20 or more items long. If you're going to ask an individual to take time to complete the instrument, you want to be sure that they're getting feedback that demonstrates that we're taking that information into consideration and we're applying it to their care.
Currently, a lot of times this falls on the provider, and as we know, the electronic health record and other data sources in the clinical context can be overwhelming to begin with. So when we talk about how to really leverage PRO, it's important that we're selecting PRO very thoughtfully: instruments that have the most relevance to our population, and then also defining those items within a PRO that are clinically actionable. For instance, if you're looking at an overall quality of life assessment, it may be that you're particularly interested in symptoms or symptom burden that could demonstrate an acute event or something that needs immediate clinical response.
That could include things like shortness of breath, pain, depression, or anxiety symptoms, for instance. Currently, that falls certainly to physicians. It may also fall to advanced practice providers, as well as nurses in the clinical setting. Regardless of whom the responsibility falls to, the most important thing is that we're clearly communicating to patients how this information is being used and what they can expect to see as a result of it. Whether it be monitoring on our side without additional communication or particular follow up for the patient based on their responses.
Excellent. So who benefits from the data, and how does it benefit them?
So the primary beneficiary of this data collection should be the patient. That's the first line of information that we can use to immediately respond to and ameliorate certain symptom burden. PROs are very important because they can allow us to detect things that a patient may or may not disclose right away. So this is important for us in the oncology setting, the Hodgkin lymphoma setting, because we want to be aware of toxicities so that we can treat them and address them as immediately as possible. Certainly it also benefits the health care community. It allows us to track and trend PRO over populations. Especially if we're evolving into a space of artificial intelligence (AI), it allows us to gather big data sets that allow us to trend and potentially predict what populations might experience, what types of side effects. Then, long-term, it benefits the research community. It allows us to get insights into how people are responding and how we, as a medical and health care community, may be able to tweak or inform patients prior to the start of therapy of what to expect. That can make the process a little bit easier for them as they go through treatment.
Given the existence of patient reporting tools, what is your advice to doctors and nurses in the treatment of classical Hodgkin lymphoma?
Absolutely. We know from Dr. Maddocks' wonderful presentation that Hodgkin lymphoma treatment is not without symptom burden and certainly both acute and potentially long-term effects. So when we're thinking about how to apply PRO to this population, we really want to be mindful that we're integrating tools that are validated specifically for the Hodgkin lymphoma community. Unfortunately, there aren't a huge amount of instruments that have been validated specifically for this population. Oftentimes we're seeing instruments that are more broadly used, such as the SF-36, some of the fact tools, etc.
Whatever tool is chosen to be used, whether it's in the context of research or clinical practice, making sure that the instrument is A.) applicable to the population and is reflective of the types of symptoms and burden that they may be experiencing; B.) that the burden of completion is as minimal as possible for the patient, so that's both in terms of the length of the instrument and the frequency with which we're asking to collect it; and C.) that if you're planning to collect, that you have a well-defined plan for who will review and what the response will be for the patient who is completing the instrumentation.
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About Dr. Brassil
Kelly Brassil, PhD, RN, is an Advanced Practice Nurse and the Lead Care Manager, Patient Access Support Services at The University of Texas MD Anderson Cancer. She has been named an American Academy of Nursing 2020 fellow. Her research experience includes working on patient reported outcomes for patients with acute and chronic leukemia, breast cancer, and prostate cancer.
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Basch, E, Deal AM, Dueck AC, et al (2017). Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA, 318(2):197-198. DOI:10.1001/jama.2017.7156
US Food & Drug Administration (2020). Project Patient Voice. Available at: https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice
This transcript has been edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of i3 Health.