Pilot Randomized Trial of an Educational Intervention About Immunotherapy for Patients With Advanced Cancer and Their Caregivers.

Background: Immune checkpoint inhibitors (ICIs) are widely used cancer drugs. We developed "UPLIFT," a video and question prompt list (QPL) intervention to educate patients about ICI risks and benefits.

Patients and methods: We conducted a randomized controlled trial of UPLIFT versus usual care among 130 adults initiating ICIs and caregivers. Dyads were randomized 1:1 to receive UPLIFT or usual care prior to ICI initiation. Participants completed surveys at enrollment, 72 hours, and 6 weeks post-ICI initiation. The primary outcomes were feasibility (≥70% enrollment of eligible patients and ≥80% of UPLIFT patients reviewing the video and QPL) and ICI knowledge (8 items, scored as % correct). We also assessed acceptability of UPLIFT (3 items), anxiety (6-item State-Trait Anxiety Inventory), and patient activation (number of questions asked in oncology visit). We used descriptive statistics, analysis of covariance (ANCOVA), and negative binomial models.

Results: We enrolled 130 of 178 eligible patients (73%) and 56 caregivers. Patients (mean age, 67 years [range, 31-92]) had diagnoses of melanoma (41%), lung cancer (26%), or other cancers. All UPLIFT patients (100%) watched the video; 47% used the QPL. Nearly all patients (61/65; 94%) felt "somewhat" or "very comfortable" with UPLIFT. ICI knowledge improved among UPLIFT patients versus controls at 72 hours (difference in adjusted mean % correct at 72 hours, 9% [95% CI, 3%-16%]). The change in anxiety at 72 hours did not significantly differ and there was no difference in knowledge or anxiety change at 6 weeks across groups. UPLIFT patients asked more questions (ratio, 1.27 [95% CI, 0.97-1.66]).

Conclusions: A novel educational intervention about ICI risks and benefits was feasible to deliver, deemed acceptable, and shows promise in improving knowledge and activation to ask questions without increasing anxiety. A future study evaluating UPLIFT's efficacy in these and other outcomes, including severe ICI toxicity, is warranted.