Pilot Trial of an Educational Immunotherapy Intervention for Patients with Advanced Cancer

Outcomes 1. Participants will identify knowledge about immunotherapy as an important educational target for adults with advanced cancer that may be addressed through a video and question prompt list intervention.2. Participants will be able to appraise the feasibility of one approach to improving patient and caregiver knowledge about immunotherapy for advanced cancer. Key Message Immunotherapy has revolutionized cancer treatment and causes novel toxicities that are important for patients to understand. We developed a video and question prompt list intervention to educate patients about immunotherapy. In a randomized controlled trial, we found that the intervention was feasible to deliver, acceptable, and improved immunotherapy knowledge versus usual care among adults with advanced cancer, without increasing anxiety. Introduction Immune checkpoint inhibitors (ICIs) improve cancer survival and cause novel toxicities. We developed UPLIFT (Understanding and Preparing for Life on Immunotherapy), an educational video and question prompt list (QPL) intervention for adults initiating ICIs. Objectives To test the feasibility and acceptability of UPLIFT and its effects on immunotherapy knowledge and anxiety. Methods We conducted a pilot randomized controlled trial (NCT04670445) of UPLIFT among adults initiating an ICI for advanced cancer. Participants were randomized 1:1 to receive UPLIFT prior to ICI initiation or usual care. Participants completed surveys at enrollment (baseline), within 72 hours after ICI initiation (72h), and at 6 weeks. The primary outcome was feasibility (70% enrollment among approached patients and 80% video completion and QPL review). We also assessed acceptability, immunotherapy knowledge (8-item survey, scored as % correct), and anxiety (State and Trait Anxiety Index-Short Form). We used ANCOVA models to analyze knowledge and anxiety outcomes. Results We enrolled 130 of 178 approached, eligible patients (73%). 66 patients were randomized to receive UPLIFT and 65 to control. Patients (38% female, mean age=67y) had diagnoses of melanoma (40%), lung cancer (26%), or other cancers (34%). All 66 (100%) patients assigned to UPLIFT watched the video and received the QPL. 94% of patients were “somewhat” or “very comfortable” with UPLIFT. Immunotherapy knowledge improved from baseline to 72h among patients assigned to UPLIFT relative to control (difference in adjusted mean % correct: 9% [95% CI: 3% - 16%]). The change in anxiety from baseline to 72h did not significantly differ between groups (0.6, 95% CI: -2.6 - 3.8). There were no between-group differences in knowledge or anxiety score change from baseline to 6 weeks. Conclusion A novel educational intervention was feasible to deliver, acceptable, and improved immunotherapy knowledge relative to usual care among adults with advanced cancer, without increasing anxiety. Keywords Communication / Disease specific management