Pilot Randomized Controlled Trial of an Educational Video for CAR T-Cell Therapy Recipients
Author:
Johnson P. Connor12, Dhawale Tejaswini12, Newcomb Richard A.12, Barata Ana23, Karpinski Kyle3, Lavoie Mitchell W.4, Vaughn Dagny5, Hennessey Kathleen1, Schneider David3, Amonoo Hermioni L.267, Volandes Angelo12, El-Jawahri Areej12
Affiliation:
1. Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital, Boston, MA 2. Harvard Medical School, Boston, MA 3. Department of Psychiatry, Massachusetts General Hospital, Boston, MA 4. UMass Chan Medical School, Worchester, MA 5. University of Tennessee Health Science Center College of Medicine, Memphis, TN 6. Department of Psychiatry, Brigham and Women’s Hospital, Boston, MA 7. Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA
Abstract
Background: CAR T-cell therapy has transformed the treatment of hematologic malignancies, but it 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-cell therapy. Methods: We conducted a randomized controlled trial comparing an educational video versus usual care in adults (age ≥18 years) with hematologic malignancies receiving CAR T-cell therapy at Massachusetts General Hospital. Intervention participants watched a 13-minute video depicting how CAR T-cell therapy works, logistics, toxicities, prognosis, recovery, and approaches for dealing with prognostic uncertainty. The primary outcome was feasibility (≥60% enrollment rate). Secondary outcomes included acceptability (≥80% reporting comfort with the video), patients’ knowledge about CAR T-cell therapy (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-cell therapy. Results: We enrolled 79% (80/101) of eligible patients. Of that group, 91% (30/33) reported being very or somewhat comfortable watching the video, and 94% (31/33) would definitely or probably recommend the video. At 1 month, participants in the video arm reported higher self-efficacy (mean difference [MD], 9.2 [95% CI, –4.0 to 22.3]; Cohen’s d, 0.32), decision satisfaction (MD, 2.5 [95% CI, 0.7–4.2]; Cohen’s d, 0.67), and lower anxiety (MD, –0.8 [95% CI, –2.5 to 0.7]; Cohen’s d, 0.26) compared with participants in the usual care arm. At 1 week, both arms reported high preferences for CAR T-cell therapy (video arm, 94% [33/35]; usual care, 84% [27/32]). Conclusions: We found that an educational video for patients receiving CAR T-cell therapy was feasible and acceptable. The educational video demonstrated promising preliminary effects on patient self-efficacy and decision satisfaction and warrants further study.
Publisher
Harborside Press, LLC
Reference39 articles.
1. Chimeric antigen receptor T cells for sustained remissions in leukemia;Maude SL,2014 2. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma;Neelapu SS,2017 3. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma;Schuster SJ,2019 4. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study;Abramson JS,2020 5. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study;Berdeja JG,2021
|
|