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

Cancers

Edmondo J. Robinson¹  Rodrigo Carvajal²  Melissa Alsina³  Frederick L. Locke³  Doris K. Hansen³  Kedar Kirtane⁴  Aasha I. Hoogland⁵  Lisa M. Gudenkauf⁵  Brian D. Gonzalez⁵  Yvelise Rodriguez⁵  Nathaly Irizarry-Arroyo⁵  Laura B. Oswald⁵  Xiaoyin Li⁵  Heather S. L. Jim⁵ 

[1] Center for Digital Health, Moffitt Cancer Center, Tampa, FL 33612, USA;Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL 33612, USA;Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL 33612, USA;Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA;Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 USF Magnolia Dive, MFC-HOB, Tampa, FL 33612, USA;

关键词: feasibility studies;    hematologic neoplasms;    immunotherapy;    adoptive;    patient-reported outcome measures;    wearable electronic devices;   

DOI  :  10.3390/cancers14112742

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown