Pilot Randomized Controlled Trial of an Educational Video for Chimeric Antigen Receptor (CAR)-T Cell Therapy Recipients
Authors: Johnson Patrick Connor , Dhawale Tejaswini , Newcomb Richard , Barata Anna , Karpinski Kyle , Lavoie Mitchell , Vaughn Dagny , Hennessey Kathleen , Scheider David , Amonoo Hermioni L , Volandes Angelo , El-Jawahri Areej 
Published: December 2023

Background: CAR-T cell therapy has transformed treatment of hematologic malignancies but is complex and challenging to convey to patients. Educational video interventions are efficacious for improving patient knowledge about cancer therapeutics and informing their care preferences; yet, no educational videos have been evaluated in CAR-T.

Methods: We conducted a randomized controlled trial comparing an educational video versus usual care in adults (&gt;18 years) with hematologic malignancies receiving CAR-T at Massachusetts General Hospital. Intervention participants watched a 13-minute video depicting how CAR-T works, logistics, toxicities, prognosis, recovery, and approaches to deal with prognostic uncertainty. Participants were permitted to watch the video a single time without interruption and were not given any further access or exposure to the video. The educational video arm also received usual clinical care. At our institution usual care includes a verbal discussion about CAR-T with a physician and nurse navigator along with written documentation about CAR-T. The primary outcome was feasibility (&gt;=60% enrollment rate). Secondary outcomes included acceptability (&gt;=80% reporting comfort with the video), patients' knowledge about CAR-T (10-item test), and self-efficacy (Communication and Attitudinal Self-Efficacy Scale-Cancer), decision satisfaction (Decision Conflict Scale), psychological distress (Hospital Anxiety and Depression Scale), and preference for CAR-T. Given the pilot nature of this study, we determined Cohen's d effect sizes for differences in knowledge, self-efficacy, decision satisfaction, anxiety, and depression between both groups at the 1 week and 1 month timepoints, with Cohen's d effect sizes of 0.2, 0.5, and 0.8 denoting small, medium, and large effect sizes, respectively.

Results: Eighty participants were randomly assigned to the video (N=40) and the usual care (N=40) arms. Among all participants, most were White (93%), male gender (68%), married or living with a partner (80%), and college educated (54%). The most common cancer diagnosis was non-Hodgkin lymphoma (74%), followed by multiple myeloma (24%) and acute lymphoblastic leukemia (3%) [Table 1]. The primary endpoint of feasibility was met, as we enrolled 79% (80/101) of eligible patients. The video was highly acceptable to patients: 91% (30/33) reported being very or somewhat comfortable watching the video, 90.9% (30/33) reported the video was very or somewhat helpful, and 94% (31/33) would definitely or probably recommend the video. At 1 week, video arm participants reported higher self-efficacy (mean difference [MD]=19.4, 95% confidence interval [CI] 7.5-31.4, Cohen's d 0.8) and decision satisfaction (MD=1.6, 95% CI [0.1-3.1], Cohen's d: 0.5) compared to usual care participants. At 1 week, both arms reported high preferences for CAR-T (video arm: 94% [33/35]; usual care: 84% [27/32]). At 1 month, video arm participants reported higher self-efficacy (MD=9.2, 95% CI [-4.0-22.3], Cohen's d: 0.3) and decision satisfaction (MD=2.5, 95% CI [0.7-4.2], Cohen's d: 0.7) and lower anxiety (MD= -0.9, 95% CI [-2.5-0.7], Cohen's d: 0.3) compared to usual care participants (Table 2). Knowledge scores were high in both arms throughout all time points and were similar between groups at 1 week (MD=0.0, 95% CI [-0.7-0.7], Cohen's d 0.0) and 1 month (MD=0.1, 95% CI [-0.6-0.7], Cohen's d: 0.1). Depression scores were similar between groups at 1 week (MD= -0.3, 95% CI [-2.0-1.3], Cohen's d: 0.1) and 1 month (MD= -0.3, 95% CI [-2.2-1.7], Cohen's d: 0.1).

Conclusions: We found that an educational video in patients with hematologic malignancies receiving CAR-T was feasible and highly acceptable to patients. We also demonstrated promising preliminary effects on self-efficacy, decision satisfaction, and anxiety. We identified only modest changes in knowledge scores, likely due to a ceiling effect from high knowledge scores at baseline. Our results highlight the potential utility of videos for improving the care delivery of patients receiving CAR-T and support a future large efficacy trial to definitively assess the impact of the video on patient-reported outcomes and care delivery.