Randomized Clinical Trial of the MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
研究概览
简要总结
Randomized unblinded interventional clinical trial:
Arm Intervention Experimental arm (n=150): Intervention group Administration of the MyPal ePRO system the intervention group will use the ePRO tools provided in the project.
Standard care arm (n=150): no intervention besides general palliative care if required general palliative care if required.
Patients will be randomly assigned in a 1:1 fashion to use the MyPal system and receive related-intervention versus general palliative care, stratified by cancer type (i.e. CLL vs MDS), using a computer-generated number sequence, which will be concealed until after group assignment.
详细描述
The MyPal eHealth system coincides with the MyPal intervention. The system will be used primarily by the patients that participate in the intervention arm of the trial and secondarily by the participating healthcare professionals (HCP). Patients participating in the standard arm of the trial won't use the system. Access to the MyPal eHealth system will be granted to the patients and HCP right after their enrollment in the trial. Patients will have access to the system continuously for 12 months; HCP will have access to the system until the end of the trial.
The main modules (software and hardware) of the system are outlined below:
- MyPal smartphone application (app). This is the interface of the patient to the system. The MyPal smartphone app is available for smartphones running on the Android and iOS operating systems and it is installed on the personal smartphone of the patient.
- Commercial smart wristband. This is a commercial activity tracking device that will be employed for monitoring the physical activity and the sleep quality of the patient, provided by the site personnel. Wearable to be worn. Ionic™ (Fitbit) will be employed by the trial as the smart wristband.
- MyPal web application (app). This is the main interface of the HCP to the system. It is accessible as a web portal through any modern web browser.
- System backend. This module resides at the backend of the system and it is not directly accessible by the aforementioned types of users. The system backend interfaces the MyPal smartphone app and the MyPal web app.
In brief, the intervention revolves around the reporting by the patient of physical and psycho-emotional symptoms (via the MyPal smartphone app) and the immediate delivery of the reported symptom-related information to the HCP (via the MyPal web app). Of note, the reported symptom-related information becomes instantly available to the HCP in the MyPal web app; however, this does not imply that the HCP is guaranteed to review it at the same time. The intervention is described in more detailed below, first from the standpoint of the patient and then from that of the HCP.
The patients interact with the MyPal smartphone app in 3 sequential phases. Additionally, during the enrollment in the study, the patients are handed the commercial smart wristband and they are instructed to wear it as much as possible (also while sleeping) throughout their participation in the study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or myelodysplastic syndrome (MDS)
- •Scheduled to receive any line of treatment for CLL/SLL or MDS or who have been previously exposed to any treatment for CLL or MDS
- •Able to understand and communicate in the respective language
- •Users of an Internet connected device (smart phone/tablet)
排除标准
- •Patients who are already participating in another experimental study
- •Patients needing immediate referral for specialized palliative care
- •Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- •Patients unable to provide written informed consent
- •Life expectancy <3 months
- •For CLL cohort: patients who have experienced Richter transformation
结局指标
主要结局
Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
时间窗: through study completion, an average of 1 year
The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
Improvement in EuroQol (EQ)-five dimensions (5D)
时间窗: through study completion, an average of 1 year
The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EuroQol (EQ)-five dimensions (5D).
次要结局
未报告次要终点