Oswald Laura B, Li Xiaoyin, Carvajal Rodrigo, Hoogland Aasha I, Gudenkauf Lisa M, Hansen Doris K, Alsina Melissa, Locke Frederick L, Rodriguez Yvelise, Irizarry-Arroyo Nathaly, Robinson Edmondo J, Jim Heather S L, Gonzalez Brian D, Kirtane Kedar
Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 USF Magnolia Dive, MFC-HOB, Tampa, FL 33612, USA.
Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL 33612, USA.
Cancers (Basel). 2022 May 31;14(11):2742. doi: 10.3390/cancers14112742.
Background: Clinicians must closely monitor patients for toxicities after chimeric antigen receptor T-cell therapy (CAR-T). Patient-reported outcomes (PROs) (e.g., toxicities, quality of life) and activity data (e.g., steps, sleep) may complement clinicians’ observations. This study tested the feasibility and acceptability of collecting PROs and activity data from patients with hematologic malignancies during CAR-T and explored preliminary data patterns. Methods: Participants wore a Fitbit tracker and completed PROs at several timepoints through 90-days post-infusion. Feasibility was assessed with a priori benchmarks for recruitment (≥50%), retention (≥70%), PRO completion (≥70%), and days wearing the Fitbit (≥50%). Acceptability was assessed with participant satisfaction (a priori benchmark > 2 on a 0−4 scale). Results: Participants (N = 12) were M = 66 years old (SD = 7). Rates of recruitment (68%), retention (83%), PRO completion (85%), and days wearing the Fitbit (85%) indicated feasibility. Satisfaction with completing the PROs (M = 3.2, SD = 0.5) and wearing the Fitbit (M = 2.9, SD = 0.5) indicated acceptability. Preliminary data patterns suggested that participants with better treatment response (vs. progressive disease) had a higher toxicity burden. Conclusions: Longitudinal PRO and activity data collection was feasible and acceptable. Data collected on a larger scale may be used to specify risk prediction models to identify predictors of severe CAR-T-related toxicities and inform early interventions.
背景:嵌合抗原受体T细胞疗法(CAR-T)后,临床医生必须密切监测患者的毒性反应。患者报告的结局(PROs)(如毒性反应、生活质量)和活动数据(如步数、睡眠)可补充临床医生的观察结果。本研究测试了在CAR-T治疗期间从血液系统恶性肿瘤患者中收集PROs和活动数据的可行性和可接受性,并探索了初步的数据模式。方法:参与者佩戴Fitbit追踪器,并在输注后90天内的多个时间点完成PROs。通过招募(≥50%)、留存率(≥70%)、PRO完成率(≥70%)和佩戴Fitbit的天数(≥50%)的先验基准评估可行性。通过参与者满意度(先验基准在0-4量表上>2)评估可接受性。结果:参与者(N=12)的平均年龄M=66岁(标准差SD=7)。招募率(68%)、留存率(83%)、PRO完成率(85%)和佩戴Fitbit的天数(85%)表明具有可行性。对完成PROs(M=3.2,SD=0.5)和佩戴Fitbit(M=2.9,SD=0.5)的满意度表明具有可接受性。初步数据模式表明,治疗反应较好(与疾病进展相比)的参与者毒性负担更高。结论:纵向PRO和活动数据收集是可行且可接受的。更大规模收集的数据可用于指定风险预测模型,以识别严重CAR-T相关毒性的预测因素并为早期干预提供信息。
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