At the recent American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, Debra Lundquist, PhD, RN, of Massachusetts General Hospital and colleagues presented their poster that sought to bridge the gap between recent advances in individual therapy which led to improved outcomes and a better understanding of patient-reported hope, quality of life, symptom burden, and coping mechanisms in early phase clinical trial participants.
Oncology Data Advisor: Welcome to Oncology Data Advisor. Today I'm joined by Dr. Deb Lundquist, Clinical Research Nurse from Massachusetts General Hospital. Recently, she provided a presentation at the 2022 ASCO Annual Meeting titled Patient-Reported Hope, Quality of Life, Symptom Burden, and Coping Mechanisms in Early Phase Clinical Trial Participants. Would you like to introduce yourself, what you do, and some things you are interested in?
Debra Lundquist, PhD, RN: Sure. My name is Deb Lundquist. I am a Clinical Research Nurse and Oncology Nurse Scientist in the Termeer Center for Targeted Therapies at Mass General Hospital. I've been in this position for two and a half years, and my research focuses on the patient experience. So, prior to coming to the Termeer unit, I was focused on the experience of women with advanced breast cancer; that was my dissertation research. Now my research is focused and housed in the Termeer unit, which is a phase 1 clinical trials unit for people with cancer, predominantly advanced cancer.
Oncology Data Advisor: What is the knowledge gap regarding the association of patient-reported hope with quality of life, symptom burden, and coping mechanisms for participants in early phase clinical trials?
Dr. Lundquist: There's a gap in that we have not asked those questions specifically to patients as they come on trial and have not measured it in a way where we have data in which we're then able to look at associations and correlations between some of the different patient-reported outcomes. So, we're focused on looking at about eight different outcomes and how they may be related or what associations may be playing a role, in terms of some of their clinical outcomes as well.
Oncology Data Advisor: Can you give us an overview of what you investigated in this study and the results that you found?
Dr. Lundquist: Yes. So, this study is a prospective study, and what we're doing is we're looking at understanding from the time of consent, or on the first day of a patient's participation in a phase 1 clinical trial, we're looking at specific patient-reported outcomes around quality of life, hope, coping, symptom distress, and symptom burden, both physical and psychological. We're looking at anxiety and depression as well, and then lastly, financial toxicity. So we're looking at these outcomes over time. Patients complete these surveys either on an iPad or a paper copy if that's easier for them, whatever their preference is. We're looking at it from their time of enrollment throughout their time on trial to see what changes we might see.
Additionally, for the first 51 patients, we interview them at time of enrollment as well. So that's a different study that we're reporting, but there's also a qualitative piece, looking at what matters most to them at the time of participation. We're looking at patient-reported outcomes, but we're also looking at clinical outcomes around time on trial, their ability to get through the time of the dose-limiting toxicity, which is typically about the first cycle of therapy, looking at overall survival, and then looking at utilization of health care services, particularly palliative care, social work, nutrition, and physical therapy, amongst a whole host of others.
Then looking at clinical characteristics in terms of who are they—age, gender, race, financial status, their zip code—we're looking at where they live in terms of maybe their time toxicity and burden to coming on trial. So, we're looking at a whole bunch of different things from a patient-reported perspective, as well as looking at their chart and doing a chart review as well.
Oncology Data Advisor: This is such an interesting and valuable insight to have. I'm excited to read more about the trial. Did you find any results that were surprising to you?
Dr. Lundquist: Well, we've just done a preliminary analysis of the first 85 patients, and I would say it's probably not surprising: patients that are coming to us now have high baseline hope scores. So, they are coming to us with, I would say, a mixture of feelings when people come on a phase 1 clinical trial. They're coming with hope of some benefit but also realistic awareness that the purpose of the phase 1 trial has always been, historically, to determine the maximum tolerated dose of drug. But with the new novel targeted agents that we have as part of our treatment toolbox, patients are very aware that we're targeting specific mutations, and patients are hoping that they're going to have benefit from that. So we're treating them in newer, more novel ways. I'd say the landscape of phase 1 clinical trials has really changed dramatically over the last five to 10 years.
Oncology Data Advisor: How can your findings regarding the association between patient-reported hope and quality of life be used to improve the outcomes of patients in early phase clinical trials?
Dr. Lundquist: We're hoping that by looking at these associations, we'll be able to develop targeted interventions that will help patients improve their experience while they're on trial. It may also lead to longer times on trial and certainly improve quality of life while they're on trial. As I mentioned, most of these patients have advanced cancer. Certainly, the generosity of their participation at a time where they're well aware that they're living with life-limiting illness—we're very aware of that as well. We want to be able to maximize the support and the resources as needed to provide the most benefit to patients.
Oncology Data Advisor: That's awesome. Well, thank you so much for all this information and insight. Is there anything else you would want to add?
Dr. Lundquist: I think that probably covers it. We're looking at furthering our analysis. Our enrollment continues to increase, so we're hoping that we'll have a better and more clear understanding as to how some of these baseline characteristics may all be connected to patients' experience.
Oncology Data Advisor: We're excited to hear more about it in the future.
Dr. Lundquist: Wonderful. Thanks very much, Lyn. Very nice to meet you, and thanks for the opportunity.
About Dr. Lundquist
Debra Lundquist, PhD, RN, is a Clinical Research Nurse and Oncology Nurse Scientist from the Termeer Cancer Center at Massachusetts General Hospital. She has a special interest in breast oncology and early phase clinical trials. Dr. Lundquist has presented many other posters and publications throughout the years at ASCO regarding early phase clinical trials and breast cancer.
For More Information
Lundquist D, Pelletier A, Durbin S, et al (2022). Patient-reported hope, quality of life (QOL), symptom burden, and coping mechanisms in early phase clinical trial participants. J Clin Oncol (2022 ASCO Annual Meeting Abstracts), 40(suppl_16). Abstract 12114. DOI:10.1200/JCO.2022.40.16_suppl.12114
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.