Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 13
- 主要终点
- The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
研究概览
简要总结
This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing, symptom burden and daily functioning. This study will capture useful information on the impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned collection of PRO and physician-reported adverse events ad early time point will help to compare and integrate these two points of view in healthcare assessment.
详细描述
Quality of life assessment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma.
- •Scheduled to received CAR-T cell product.
- •Having a baseline PRO assessment.
- •Adult patients (≥ 18 years old).
- •Written informed consent provided.
排除标准
- •Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
- •Not able to read and understand local language.
研究组 & 干预措施
Quality of life assessment
Quality of life questionnaires
结局指标
主要结局
The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
时间窗: at 12 months
To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
次要结局
- The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire(at 12 months)
- The time to improvement in the PROMIS-Fatigue score(After 2 years from date of registration)
- The time to improvement in the QLQ-NHL-HG29 questionnaires(After 2 years from date of registration)
- The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.(After 2 years from date of registration)
- Factors predicting response to therapy and survival outcomes(After 2 years from date of registration)
- The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.(After 2 years from date of registration)
- Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians.(After + 10 day for infusion)
- The time to improvement in the EORTC QLQ-C30 questionnaires(After 2 years from date of registration)
- The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.(After 2 years from date of registration)
- The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.(After 2 years from date of registration)
- The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.(After 12 and 24 months from date of registration)
- The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.(After 12 and 24 months from date of registration)