Background: Evidence exists showing that enabling patients to engage in treatment decisions through education and shared decision-making is an effective tool in promoting self-efficacy, reducing barriers to care, and increasing the perceived benefits of self-involvement in one’s cancer diagnosis and treatment plan. However, there is a gap in published evidence to inform researchers on the most appropriate and relevant questions that should be asked in prospective research studies when collecting patient-reported outcome measures (PROMs). Lumicell, Inc focuses on technology that identifies cancer at the molecular level, enabling surgeons to act in real time to improve patient outcomes. An upcoming pivotal trial at Lumicell seeks to incorporate PROMs to better address the needs of patients.
Objective: Lumicell’s lead product, the LUM Imaging System, consists of a fluorescent drug, a hand-held wide-field detector (LUM Imaging Device) used to image the surgical cavity walls intraoperatively, and a proprietary tumor-detection algorithm that highlights regions in the tumor bed suspected to contain residual cancer. Patient advisory boards will be convened to collect information to define PROMs that are important to cancer patients but not covered in a comprehensive way by existing disease-focused patient advocacy organizations. The information generated from these organized sessions will be used to help define outcome measures in the upcoming pivotal study.
Method: Lumicell is developing an advisory board consisting of patient representatives and at least 3 medical researchers to reflect a variety of settings. Advisory boards will be held at 3 time points during the continuum of care, including newly diagnosed patients, patients who have recently undergone a surgical procedure, and patients who underwent their surgical procedure at least 3 months prior. Collecting data at these time points will facilitate a robust assessment of how the concerns and priorities of cancer patients change over time in relation to their cancer diagnosis and treatment. Lumicell is partnering with existing advocacy groups to support the successful execution of this project.
Results: Results are pending but proposed outcomes include (1) bringing stakeholders (patients and researchers) together to identify gaps in current medical research that reflect the concerns of the stakeholders, (2) presenting draft research protocols to the advisory board which will reflect our mutual goals of collecting the most appropriate evidence that matters most to these stakeholders and also address unmet needs, and (3) meeting with the advisory board as the research progresses to discuss insights and disseminate results generated from this project. Results from this project will help inform stakeholders as to what information is valuable to collect from and disseminate to similar patient populations.
Conclusion: The FDA has addressed the importance of placing patients and their care partners at the center of the regulatory decision-making process by incorporating patient perspective and encouraging the inclusion of PROMs in a publication series known as The Voice of the Patient. Lumicell seeks to build on these recommendations and improve PROMs through the development of advisory boards and active patient input on what is important to patients in clinical research.
