Oncology Data Advisor: Welcome to Oncology Data Advisor, I'm Keira Smith. Today I'm joined by Dr. Lisa Gudenkauf, who is an Applied Research Scientist in Health Outcomes and Behavior at Moffitt Cancer Center. She's here today to discuss her research regarding patient-reported outcomes for prostate cancer, which was recently presented at the ASCO Genitourinary Cancers Symposium.

Dr. Gudenkauf, thank you so much for coming on today.

Lisa Gudenkauf, PhD: Hi, my name is Lisa Gudenkauf. I'm an Applied Research Scientist at Moffitt Cancer Center. That means I research quality of life and treatment outcomes among cancer patients in the Department of Health Outcomes and Behavior.

Oncology Data Advisor: So, I'm excited to learn more about this patient-reported outcomes measure. My first question is, how did this study come about, and why did you decide to focus on this setting specifically?

Dr. Gudenkauf: Our principal investigator, Dr. Brian Gonzalez, really wanted to develop a patient-reported outcomes measure that would capture the patient experience with radionuclide therapy, which is often used for advanced prostate cancer. We wanted to know, in this setting with these patients and with this particular treatment, what are patients experiencing in terms of toxicities? Any patient-reported outcomes measure is very important to include in a clinical trial, and we also want to know the patient experience in the clinical setting. Without a very specific, tailored measure in existence, we wanted to make sure we provided that so that it would be available and we'd be hearing the patient's voice.

Oncology Data Advisor: How did you and your team go about designing the measure?

Dr. Gudenkauf: It was a multi-step process, and we first went to the patients directly. We asked them in qualitative interviews, "What is the experience you're having? What are the symptoms you're experiencing?" We also asked caregivers, and we asked clinicians. We wanted to get everyone's experience and everyone's input on what they're observing in terms of toxicities or symptoms that patients have.

Once we had this general sense from the qualitative interviews, we then selected items that would match those reported symptoms from the FACIT item library, which is a validated item library available online. We went from that to developing a tailored measure. Once we had the measure sort of written down, we went back to the patients, and we went back to the clinicians. We asked them, "What do you think of these? Does this capture the experience? Is there anything missing? Is there anything that you would take out that's not as important?" Then we finalized the measure with the items that we have. We wanted to make sure it was brief so it would be usable, and we're in the process now of validating the measure in multiple different clinical settings around the world.

Oncology Data Advisor: That's great. So, this is a very patient-centered process; what are some of the specific patient-related factors that the measure is looking for?

Dr. Gudenkauf: There's a broad range of symptoms we're looking at—physical symptoms, quality-of-life symptoms, and just general functioning. To give you two examples, we know that dry mouth is a common side effect of radionuclide therapy. Sometimes that can even be treatment-limiting, so we made sure we included that. We also were surprised by some of the qualitative interview responses, one of them being that patients felt isolated after their radionuclide treatment. We wanted to make sure that we included that sense of isolation as one of the items, because it's important to know about. It's important to reach out to these patients and provide social support when they're feeling isolated.

Oncology Data Advisor: Right. So, you mentioned that the measure is currently being validated. What are some of the settings where you expect that health care providers as well as investigators can start to use it in the future?

Dr. Gudenkauf: We hope it'll be used across many different types of settings and across time. We're first implementing it in a number of different cancer centers, often National Cancer Institute (NCI)–designated cancer centers or cancer center collaborators in other countries. They are implementing it in the context of clinical trials and in their routine clinical care.

Once we know more about how it's being used in those two settings, then we'll be able to determine if it's appropriate for use as a pretreatment assessment. Can we determine if patients are having too many symptoms and toxicities to move ahead with the treatment plan? Will that change the course or the dosing of radionuclide therapy? After that, we'll know more about long-term outcomes. Can we determine if these symptoms stick around? Do they stay for a long time, or do they resolve briefly after treatment?

We'll know more as we see it in use, but we're excited to have it being used across so many different sites with so many collaborators. This work is really a product of a huge team of people who have all come together to make this possible.

Oncology Data Advisor: That'll be really exciting to start seeing it being used in the future. Anything else you would like to mention?

Dr. Gudenkauf: Yes, thank you. I'd like to acknowledge the Department of Defense, which funded this research. I'd also like to acknowledge our collaborators. There are too many to mention by name, but again, Dr. Brian Gonzalez is the Principal Investigator, and he has a great team behind him. We're happy to be spreading the word about this patient-reported outcome measure, especially because it allows the patient's voice to be heard directly.

Most of all, we want to thank the patients who participated in this research and allowed us to have a better understanding of what they're experiencing. We hope that we can turn around and serve those patients better in the future with this measure.

Oncology Data Advisor: Absolutely. Thanks you so much for coming on today and explaining all this.

Dr. Gudenkauf: It's been a pleasure to talk with you.

About Dr. Gudenkauf

Lisa Gudenkauf, PhD, is a Research Scientist in the Department of Health Outcomes and Behavior at Moffitt Cancer Center in Tampa, Florida, and a licensed Clinical Psychologist. She previously served as a Senior Associate Consultant and Assistant Professor of Psychology at Mayo Clinic, where she helped develop and lead clinical intervention programs to enhance quality of life and increase health-promoting behaviors among patients with cancer. At Moffitt Cancer Center, Dr. Gudenkauf's research aims to characterize and measure psychosocial effects of cancer and its treatment to identify risk and protective factors, with a focus on positive adaptation, and to develop and test psychosocial interventions to reduce symptom burden and enhance quality of life for diverse cancer populations.

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Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.