Speaker
Ethan Basch, MD, MSc
Richard M. Goldberg Distinguished Professor and Chief of Oncology
Physician-in-Chief, North Carolina Cancer Hospital
Director, Cancer Outcomes Research Program
University of North Carolina
Keywords
Patient-reported outcomes, Oncology, Clinical Trials
Key Points
- Symptoms are common in cancer care. They interfere with physical function and daily activities, lead to avoidable ER/hospital visits and readmissions, and preclude treatment. Symptom management is a cornerstone of quality care, but do we adequately detect and manage symptoms?
- In the standard approach to symptom monitoring, the clinical team may not be aware of a patient’s symptoms, so when the symptoms become worse the care team has to be reactive. In a model for systematic symptom monitoring, a patient might report symptoms electronically in real-time via e-reports or e-alerts so the care team can respond proactively and have data to review at the next visit.
- Clinicians think they know how patients are doing already and do not need self-reported data; however in a study that compared patient-reported and clinician-reported symptoms, there was a substantial gap between the symptoms that were reported by patients and symptoms that were not reported by clinicians. There is an opportunity to do better through navigation, portals, and patient-reported outcomes to bridge the gap.
- We conducted a large single-center “STAR” Study to find out if the gap between patient and clinician reported symptoms makes an impact on clinical outcomes. There were 766 patients enrolled in the study with a median follow up of 7 years. Quality of life (QOL) was assessed at 6 months. Compared to standard care, 31% more patients in the self-reporting arm experienced QOL benefits; 7% fewer patients in self-reporting arm visited the ER with durable effects throughout the study; and median survival was 5.2 months longer among patients in the self-reporting arm. There was a 5-year absolute survival benefit of 8%.
- Proactive monitoring prompts clinicians to act early before symptoms worsen and cause downstream complications. Symptom control enables patients to stay more functional, which is known to be associated with better survival. Symptom monitoring enables control of chemotherapy side effects, enabling more intensive and longer duration of cancer treatment.
- The PRO-TECT Cancer Symptom Study was a cluster randomized trial at 52 U.S. community oncology practices across 25 states. At each practice up to 50 patients with metastatic cancer, receiving systemic therapy, not on a therapeutic trial, were randomized to an intervention arm with digital monitoring or a control arm with usual care. The intervention arm had to complete weekly PRO survey items from NCI PRO-CTCAE (pain, nausea, vomiting, constipation, diarrhea, dyspnea, insomnia, depression, oral intake).
- In this study adherence with week ePROs was 91.5%. When patients didn’t report, they received a phone call to make sure they were OK. In the PRO arm there was a statistically significant improved physical function score, the study found significant benefits for the PRO arm for symptoms, and significant benefits on health-related quality of life.
- Patient self-reporting improves symptom monitoring and outcomes in routine cancer care and clinical research by expanding our understanding of the patient experience and engaging patients. From a health services research perspective, it demonstrates how hard it is to change a simple process, even if it makes a lot of intuitive sense.
Learn more
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Discussion Themes
– How have clinician views changed in terms of patient-reported symptoms verses clinician understanding of symptoms? The culture has fundamentally changed. The research in this area has grown over time. 10 years ago or even 5 years ago many clinicians had not heard about patient-reported outcomes. Now almost any physician has heard of patient-reported outcomes. Technology has advanced during this time, and there are all kinds of ways for patients to communicate with providers. Regulatory authorities have become interested in PROs and it is thought of as a fundamental part of drug development. I have seen a remarkable change in views on patient-reported outcomes.
– How do we take all of these ePRO options and choose something that is right for a trial? It depends on the goals of the study. When you have more than one choice for the symptom domain or you run the risk of duplication how do you choose? FDA and other regulatory authorities want to think about symptoms separately from adverse events. You will want a dedicated tool for adverse events.
Tags
#pctGR, @Collaboratory1