Integrating Personalized Risk Information in Low-Dose CT (LDCT) Screening for Lung Cancer
The objective of this study is to integrate personalized risk information in lung cancer screening with Low-Dose Computed Tomography (LDCT).
LDC screening has recently been shown to reduce deaths from lung cancer—the leading cause of cancer mortality in Maine and nationwide—in high-risk patients. It is now recommended by numerous professional organizations and approved as a covered service by the U.S. Centers for Medicare and Medicaid Services (CMS), and offers great potential for reducing cancer mortality in Maine.
Yet LDCT screening also poses several challenges that call for a cautious dissemination approach. These include its unknown benefit for individuals, high false-positive test rate (approximately 25%), and potential harms from radiation exposure.
Professional organizations have thus recommended—and CMS has required—that patients be informed about the benefits, harms, and uncertainties of LDCT, through a process of shared decision making (SDM), before undergoing screening.
Another strategy receiving growing support is the integration of personalized cancer risk information (PCRI)—i.e., evidence-based estimates of an individual’s risk of lung cancer, based on his or her unique risk factors—in the screening process. PCRI is now obtainable from several clinical prediction models (CPMs)—multivariate statistical algorithms that utilize risk factor data to calculate an individual’s personal risk of lung cancer.
PCRI from these models could help maximize the benefits and minimize the harms of LDCT screening in two main ways. During pre-screening SDM counseling, PCRI could help patients make screening decisions that are better informed and matched to their own cancer risks and risk tolerance. During post-screening result disclosure, PCRI could reduce unwarranted patient concern resulting from abnormal test results—most of which are associated with a very low likelihood (<1%) of malignancy. Yet the optimal approaches to integrating PCRI in LDCT screening remain to be determined.
The proposed study aims to address this knowledge gap. Its specific aims are the following:
1. To develop, implement, and evaluate a pre-screening SDM counseling process incorporating personalized estimates of the risk of developing lung cancer given an individual’s own cancer risk factors.
2. To develop, implement, and evaluate a post-screening positive (abnormal) LDCT result disclosure process incorporating personalized estimates of the risk of having lung cancer based on an individual’s own LDCT abnormalities and cancer risk factors. These new processes will be integrated within an existing successful LDCT screening program, utilizing validated CPMs. A mixed methods evaluation (qualitative and quantitative) will explore the feasibility, acceptability, and effects of PCRI on patient-centered outcomes including decision making, knowledge, emotional distress, and adherence to recommended nodule follow-up. The study will produce a new model for LDCT screening, and pilot data that will inform future definitive research to evaluate the effectiveness of PCRI in maximizing the benefits of screening while minimizing its harms.