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255 Pilot Randomized Controlled Trial of an Educational Video for Chimeric Antigen Receptor (CAR)-T Cell Therapy Recipients

Program: Oral and Poster Abstracts
Type: Oral
Session: 902. Health Services and Quality Improvement – Lymphoid Malignancies: Innovative Care in CAR-T Therapy
Hematology Disease Topics & Pathways:
Research, clinical trials, adult, Clinical Practice (Health Services and Quality), Clinical Research, patient-reported outcomes, Study Population, Human
Saturday, December 9, 2023: 2:30 PM

Patrick Connor Johnson, MD1, Tejaswini Dhawale, MD2*, Richard Newcomb, MD2*, Anna Barata2*, Kyle Karpinski2*, Mitchell Lavoie3*, Dagny Vaughn, MS4, Kathleen Hennessey2*, David Scheider, B.S.2*, Hermioni L Amonoo, MD5, Angelo Volandes, M.D., M.P.H.2* and Areej El-Jawahri, MD2

1Cancer Center, Massachusetts General Hospital, Boston, MA
2Massachusetts General Hospital, Boston, MA
3University of Massachusetts Chan Medical School, Worchester, MA
4University of Tennessee Health Science Center College of Medicine, Memphis, TN
5Dana-Farber Cancer Institute, Boston, MA

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 (>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 (>=60% enrollment rate). Secondary outcomes included acceptability (>=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.

Disclosures: Johnson: Medically Home: Research Funding; Abbvie: Consultancy; Incyte: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding; ADC Therapeutics: Consultancy; Seagen: Consultancy; Bristol Myers Squibb: Consultancy. Newcomb: Vertex: Current equity holder in publicly-traded company, Other: Spouse employment; Timedoc: Divested equity in a private or publicly-traded company in the past 24 months. Barata: Grifols: Current equity holder in publicly-traded company; Almirall: Current equity holder in publicly-traded company. Volandes: ACP Decisions, a non-profit organization developing advance care planning video decision support tools: Other: President of ACP Decisions, a non-profit. El-Jawahri: GSK: Consultancy; Incyte Corporation: Consultancy; Novartis: Consultancy.

*signifies non-member of ASH