A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility (enrollment and retention rates)
研究概览
简要总结
The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer.
- Educational video tool for patients receiving CAR-T cell therapy.
详细描述
This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.
The research study procedures include screening for eligibility, randomization and a series of questionnaires
Participants will be randomized to one of 2 groups:
- Group A: Educational video tool
- Group B: Standard care
Participants will be in the research study for a month after consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •18 years or age or older
- •Established diagnosis of a hematologic malignancy
- •Under consideration for CAR T-cell therapy at Massachusetts General Hospital
排除标准
- •Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study
- •Undergoing CAR T-cell therapy for solid tumor malignancy
- •Inability to comprehend English, as the video is currently only available in English at this time
结局指标
主要结局
Feasibility (enrollment and retention rates)
时间窗: Up to 1 year
The primary endpoint is feasibility. The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.
次要结局
- Patient's self-efficacy (modified version of CASE-cancer)(up to 1 month)
- Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)(up to 1 week)
- Acceptability of the video (intervention arm only)(up to 1 month)
- Decision Satisfaction around receipt of CAR-T cell therapy(up to 1 month)
- Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)(up to 1 month)
- Psychological distress (Hospital Anxiety and Depression Scale (HADS)(up to 1 month)
研究者
Patrick C. Johnson, MD
Principal Investigator
Massachusetts General Hospital