Randomized Controlled Trial of a Supportive Care Digital Application (THRIVE-CAR-T) for Patients Receiving CAR-T Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this clinical trial is to learn if a digital mobile application called THRIVE-CAR-T is helpful for the care of patients undergoing CAR-T cell therapy. The main question[s] it aims to answer are whether the THRIVE-CAR-T app is feasible and acceptable to patients.
详细描述
This pilot randomized controlled trial aims to examine the feasibility, acceptability, and preliminary effects of a supportive care digital app (THRIVE-CAR-T) versus usual care in patients receiving chimeric antigen receptor T-cell therapy (CAR-T). The primary objective of the study is to determine if THRIVE-CAR-T is feasible and acceptable to patients. The exploratory objective is to assess the preliminary effects of THRIVE-CAR-T for improving patient-reported quality of life (QOL), psychological distress, and self efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Ability to understand English
- •Diagnosis of a hematologic malignancy
- •Receiving autologous CAR-T at MGH with an FDA approved cellular therapy product
排除标准
- •Impaired cognition or uncontrolled mental illness that prohibits the ability to provide informed consent based on the oncology clinician assessment
- •Already participating in another supportive care clinical trial
结局指标
主要结局
Feasibility
时间窗: Through study completion, an average of 2 years
Feasibility is defined based on the rate of patient enrollment. THRIVE-CAR-T will be deemed feasible if rates of enrollment are \>= 60%, and among those enrolled and randomized to THRIVE-CAR-T, 60% complete 3 out of 5 modules. For patients who either die prior to the end of the intervention or are admitted to the intensive care unit (ICU), the latter definition of feasibility will be completion of 60% of expected modules at the time of clinical deterioration.
次要结局
- Acceptability(Through study completion, an average of 2 years)
- Quality of life(From enrollment until 90 days after CAR-T cell therapy)
- Anxiety symptoms(From enrollment until 90 days after CAR-T cell therapy)
- Depression symptoms(From enrollment until 90 days after CAR-T cell therapy)
- PTSD symptoms(From enrollment until 90 days after CAR-T cell therapy)
研究者
Patrick C. Johnson, MD
Assistant Professor of Medicine
Massachusetts General Hospital