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

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.

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.

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]).

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.