Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of participants who access all four CC web application modules at least once
研究概览
简要总结
The complex logistics and unique toxicities of chimeric antigen receptor T-cell (CAR-T) therapy require intensive patient education and careful monitoring. The Companion for CAR-T (CC) web app may be able to assist with patient education and preparation, communication between patients and their multidisciplinary teams, and home-based toxicity monitoring.
详细描述
This is a single-arm pilot study assessing the feasibility and acceptability of the Companion for CAR-T (CC) web app among patients receiving commercially available CAR-T therapies.
Primary Objectives:
I. To evaluate the feasibility of the CC web app. II. To evaluate the acceptability of the CC web app to patients.
Secondary Objectives:
I. To quantify the incidence of fevers being reported via the CC web app. II. To quantify the incidence of electronic Immune Effector Cell-Associated Encephalopathy (eICE) deficits being recorded via the CC web app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Diagnosis of a hematologic malignancy (including any plasma cell dyscrasia, any type of lymphoma, or any type of leukemia).
- •Planned receipt of an FDA-approved CAR-T therapy at University of California, San Francisco (UCSF) as standard of care.
- •Patient proficiency in spoken and written English.
- •Caregiver proficiency in spoken and written English.
- •Age >= 18 years old
排除标准
- •FDA-approved CAR-T therapy being administered as part of a prospective industry-sponsored trial, for example registrational trials of CAR-T therapy versus salvage chemotherapy or CAR-T therapy as an off-label line of therapy.
- •*However, patients who receive an FDA-approved CAR-T therapy through an Expanded Access Program for non-conforming products (or any observational, non-interventional analysis of CAR-T products) are eligible.
- •Lack of ownership of a personal computing device, tablet device, or smartphone.
- •Refusal of patient and/or caregiver to sign up for a UCSF MyChart account.
- •*Participants and caregivers who do not have a MyChart account at enrollment but are willing to create one will receive assistance from the study team to do so.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could - in the opinion of the study's Principal Investigator (PI) - interfere with provision of informed consent or compliance with study procedures.
结局指标
主要结局
Percentage of participants who access all four CC web application modules at least once
时间窗: Up to 6 months
The percentage of participants who access all four CC web application modules at least once from the date of study enrollment through Day +100 after CAR-T therapy will be reported. To meet the acceptability criteria, a threshold of 70% of participant engagement or higher must be met.
Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application.
时间窗: 1 day
Percentage of participants agreeing or strongly agreeing with the statement, "The Companion for CAR-T web app was helpful during my experience with CAR-T therapy." from a one time assessment administered between Day +29 and Day +100 following CAR-T therapy will be reported. This question ranks the helpfulness of the CC application on a scale of 1 (strongly disagree) to 5 (strongly agree). Participants must select an item score of 4 (agree) or 5 (strongly agree). To meet the feasibility criteria, a threshold of 70% of participant agreement or higher must be met.
次要结局
- Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported(Up to 26 days)
- Number of times that temperature >= 38. degrees Celsius (°C) is reported(Up to 26 days)