SNF-CLIMEDIN: A Randomized Trial of Digital Support and Intervention in Patients With Advanced Non–Small Cell Lung Cancer. A Hellenic Cooperative Oncology Group Study

PURPOSE This trial aims to investigate the effectiveness of online digital intervention in patients with non–small cell lung cancer (NSCLC) in terms of adverse events (AEs) and quality of life (QoL). METHODS This randomized trial recruited 200 patients with advanced NSCLC (March 2022-October 2023). All patients received standard-of-care precise treatment, predominantly immunochemotherapy. The study was designed to assess AEs and QoL improvement. Through the CareAcross online platform, all patients received information about their disease and treatment and reported any of the 22 predefined AEs at any time. Patients were randomly assigned 1:1 in the intervention (A) and control (B) arm; patients in arm A automatically received, additionally, evidence-based guidance for the reported AEs. EuroQol 5-dimension 5-level responses were collected at baseline and at each treatment cycle. Resulting scores were compared between baseline and after the sixth cycle. In addition, patient case–level hospitalization data were collected and costs were estimated based on reimbursed costs as defined by the Ministry of Health, enabling a post hoc analysis. RESULTS Clinical characteristics were well-balanced. More AEs were reported by patients online versus to their clinicians ( P < .01). Among the 22 AEs, 17 improved more in arm A, with the improvement in rash and stomatitis being statistically significant. In QoL, there was no improvement in any of the five EuroQol 5-Dimension dimensions. Digital intervention was cost-saving with lower mean costs for hospitalization ( P < .001). Overall response rate, progression-free survival, and overall survival were not statistically different between the two arms, ensuring comparable clinical outcome. CONCLUSION Digital oncology tends to improve selected AEs and is cost saving. Patients report, digitally, more informative AEs. Digital oncology can be a complementary tool to the oncology team and warrants further exploration.