Maine Medical Center, Medical Education, Maine Medical Center Research Institute
Humans, Incidental Findings, Precancerous Conditions, Solitary Pulmonary Nodule
Summary: Annually, thousands of Americans learn they have pulmonary nodules found on low dose computed tomography (LDCT) within the context of lung cancer screening. These patients experience distress regarding these nodule findings, in part, due to a limited understanding of what a lung nodule is and misconceptions about the risk of cancer that they pose. This study is designed to explore the utility of a 3D printed nodule educational tool to support providers in educating patients during the lung screening shared-decision making (SDM)conversation about this commonly reported lung lesion.
Specific aims: The aim of this study is to assess the effect of adding a 3D lung nodule educational tool to the SDM conversation about LDCT lung cancer screening across two domains: Aim 1: evaluating patient distress following a finding of lung nodule and Aim 2: evaluating patient understanding of lung cancer risk from nodules. The primary outcome measure (Aim 1) will be the Score on Impact of Event Scale, which is a validated instrument of distress. This tool will be used in our primary objective of determining if the level of distress is different in the group who had SDM+3D nodule educational tool vs SDM alone among those with RADS 2-RADS 4 nodules. We hypothesize that the mean distress score in patients with a RADS2-4 nodules will be lower among those who had SDM+3D nodule educational tool vs those who had SDM alone. Our secondary outcome measure (Aim 2) will be the perceived patient risk of lung cancer on 4-point likelihoodscale. This is an investigator-developed question, used in prior surveys, that measures understanding of cancer risk depending on nodule size and characteristics (e.g.,very unlikely, somewhat unlikely, somewhat likely, very likely). This question will be used to meet our secondary objective of determining if the percent of patients with aRADS 2-RADS 4 nodules who have an accurate cancer risk understanding is different in the group who had SDM+3D nodule educational tool vs SDM alone.
General approach: We plan to conduct a randomized controlled unblinded study of adults scheduled for a SDM conversation prior to LDCT lung cancer screening at three of our participating clinics (Maine Medical Center,Southern Maine Health Center and University of Vermont Health Center). Following consent, participants will be randomized to the control arm or experimental arm. Participants in the control arm will engage in the standard SDM conversation, while participants in the experimental arm will engage in the standard SDM conversation supplemented by the 3D educational tool. The standard SDM talking points will be scripted to ensure conversations are of similar quality in each groups. Participants will receive LDCT results by mail. Two weeks later, the participants with a positive test results will receive a survey in the mail or online with questions about their level of distress/understanding of malignancy risk. We have calculated a sample size of 64 RADS 2-4 per group (128 total) will have 80% power to detect a moderate effect size (0.5) using a two group t-test with a 0.05 two-sided significance level.
Roelke, Theresa and Emery, Ivette, "Effect of 3D Lung Nodule Educational Tool on Patient Distress Following LDCT Incidental Finding of Lung Nodule" (2020). Costas T. Lambrew Research Retreat 2020. 58.