Prospective evaluation of the psychological impact of multicancer early detection (MCED) blood testing: A smartphone-based patient-reported outcomes study.

10542 Background: Earlier detection may reduce cancer mortality by reducing the number of cancers diagnosed at advanced stages. Prospective data evaluating the emotional impact of MCED testing are limited, particularly when paired with digital engagement tools. Smartphone-based applications offer an opportunity to monitor patient-reported distress in real time and provide scalable support throughout the testing journey. The Falcon registry is a large prospective study evaluating the Exact Sciences MCED test in clinically cancer-free individuals that included evaluation of patient reported outcomes (PRO) using digital tools. Methods: Falcon (NCT06589310) is a multi-site registry enrolling up to 25,000 participants, 50-80 years of age. Participants receive the MCED test annually for 3 years and complete PRO measures, including the Generalized Anxiety Disorder-7 (GAD-7) assessment. The assessment is administered via the myBSWHealth digital platform at baseline (T0), ≤14 days of receiving test results (T1), and at approximately 6 months (T2). Reminders encouraged timely survey completion, and adaptive content was delivered based on distress scores. GAD-7 scores are categorized for clinical interpretation of anxiety: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-21 severe. Clinically meaningful changes (+/->4) in anxiety severity at T0-T1 and T0-T2 were assessed. Results: 8,977/9,204 (97.5%) enrolled participants from 08/2024-01/2026 across the Baylor Scott & White Health System have an activated MyBSWHealth account. 4125 had the potential for 6-month follow-up at data analysis; 2729 (66.1%) completed ≥1 GAD-7 and 2161 (52.4%) had a T0 score. Most participants (94.9%) had minimal to mild anxiety at T0; however, a subset of participants (5.1%) demonstrated moderate to severe anxiety prior to testing. Overall, GAD-7 scores stayed within the minimal anxiety range over time with medians (interquartile ranges) of 1.00 (4.00), 0.00 (3.00) and 1.00 (4.00) at T0, T1 and T2, respectively. Among the 1219 participants who completed the GAD-7 at both T0 and T1, 86% had no clinically meaningful change in anxiety severity, 7% had a decrease, and 6% had an increase. Among the 989 participants who completed the GAD-7 at both T0 and T2, 85% had no change, 7% had a decrease, and 8% had an increase. Conclusions: Digital assessment of anxiety during MCED blood testing gives real-time data on the effects of cancer screening in an average risk population. Despite concerns about the potential for population-based cancer screening to increase anxiety, our preliminary findings suggest low levels of anxiety that remain stable in the majority of participants who completed follow-up assessments after receiving an MCED test result. Additional data for anxiety and distress using the Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) will be presented. Clinical trial information: NCT06589310 .