An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 27
- 主要终点
- HRQOL in adult patients with hematologic malignancies
研究概览
简要总结
This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of any hematologic malignancy according to 2016 WHO classification
- •Adult Patients (≥18 years).
- •Written informed consent
排除标准
- •Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- •Not able to read and understand local language
结局指标
主要结局
HRQOL in adult patients with hematologic malignancies
时间窗: After 2 years from date of registration
To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Symptoms in adult patients with hematologic malignancies
时间窗: After 2 years from date of registration
To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
Adherence to therapy in adult patients with hematologic malignancies
时间窗: After 2 years from date of registration
To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
次要结局
- Clinical strategies adopted by physicians(After 2 years from date of registration)
- Prevalence of clinically relevant functional limitations and symptoms(After 2 years from date of registration)
- Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire(After 2 years from date of registration)
- Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes(After 2 years from date of registration)
- Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes(After 2 years from date of registration)