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CAR-T 治疗期间患者报告结局和活动数据的纵向收集:可行性、可接受性和数据可视化

英文原题:Longitudinal Collection of Patient-Reported Outcomes and Activity Data during CAR-T Therapy: Feasibility, Acceptability, and Data Visualization.

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Longitudinal Collection of Patient-Reported Outcomes and Activity Data during CAR-T Therapy: Feasibility, Acceptability, and Data Visualization.

PubMed 2022/05/31(内容时间) Cancers (Basel) Q2 · IF 4.8(JCR 2025)

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中文摘要

CAR-T 细胞治疗(CAR-T)后,临床医师必须密切监测患者毒性。患者报告结局(PRO,如毒性、生活质量)和活动数据(如步数、睡眠)可补充临床观察。本研究评估在血液系统恶性肿瘤患者 CAR-T 治疗期间收集 PRO 和活动数据的可行性及可接受性,并初步探索数据模式。

参与者佩戴 Fitbit 追踪器,并在 CAR-T 输注后至第 90 天期间多个时间点填写 PRO。预先设定招募率(≥50%)、留存率(≥70%)、PRO 完成率(≥70%)和佩戴 Fitbit 的天数占比(≥50%)作为可行性标准。可接受性根据参与者满意度评估,预设基准为 0–4 分量表上超过 2 分。

参与者(N=12)平均年龄 66 岁(标准差 [SD]=7)。招募率(68%)、留存率(83%)、PRO 完成率(85%)和 Fitbit 佩戴天数占比(85%)表明该方法可行。完成 PRO 的满意度(均值=3.2,SD=0.5)和佩戴 Fitbit 的满意度(均值=2.9,SD=0.5)表明其可接受。初步数据模式提示,与疾病进展患者相比,治疗反应较好的参与者毒性负担更高。

纵向收集 PRO 和活动数据是可行且可接受的。大规模收集的数据可用于建立风险预测模型,识别 CAR-T 相关重度毒性的预测因素,并指导早期干预。

展开英文摘要原文

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.

论文信息

作者
Oswald LB、Li X、Carvajal R、Hoogland AI、Gudenkauf LM、Hansen DK、Alsina M、Locke FL
第一作者单位
Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 USF Magnolia Dive, MFC-HOB, Tampa, FL 33612, USA.United States
通讯作者单位
Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.United States
期刊
Cancers2022 May 31
原文标识
PubMed 35681722 · DOI 10.3390/cancers14112742