An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies
2021年5月13日 更新者：Gruppo Italiano Malattie EMatologiche dell'Adulto
An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
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.
研究概览
研究类型
观察性的
注册 (预期的)
400
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fabio Efficace
- 电话号码：+39 06441639831
- 邮箱：alliance@gimema.it
学习地点
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Ancona、意大利
- 尚未招聘
- Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona
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Aviano、意大利
- 尚未招聘
- Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
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Bari、意大利
- 尚未招聘
- Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
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Bari、意大利
- 招聘中
- Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia
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Barletta、意大利
- 尚未招聘
- Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia
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Cagliari、意大利
- 招聘中
- Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
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Catania、意大利
- 尚未招聘
- Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia
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Foggia、意大利
- 招聘中
- Aou Ospedali Riuniti - Foggia- UOC Ematologia
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Lecce、意大利
- 招聘中
- Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
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Modena、意大利
- 招聘中
- Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia
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Napoli、意大利
- 招聘中
- Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia
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Novara、意大利
- 招聘中
- S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara
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Palermo、意大利
- 招聘中
- Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
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Palermo、意大利
- 招聘中
- Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica
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Pescara、意大利
- 尚未招聘
- Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
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Reggio Emilia、意大利
- 招聘中
- Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia
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Roma、意大利
- 招聘中
- Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
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Roma、意大利
- 招聘中
- Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
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Roma、意大利
- 招聘中
- Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali
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Roma、意大利
- 尚未招聘
- AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
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Roma、意大利
- 招聘中
- Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
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Roma、意大利
- 招聘中
- Divisione di Ematologia - Ospedale S. Eugenio
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San Giovanni Rotondo、意大利
- 招聘中
- Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
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Sassari、意大利
- 招聘中
- Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
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Sassuolo、意大利
- 尚未招聘
- Ospedale Di Sassuolo Spa - Ematologia
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Torino、意大利
- 招聘中
- Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
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Torino、意大利
- 尚未招聘
- Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult patients diagnosed with any hematologic malignancy
描述
Inclusion Criteria:
- Diagnosis of any hematologic malignancy according to 2016 WHO classification
- Adult Patients (≥18 years).
- Written informed consent
Exclusion Criteria:
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- Not able to read and understand local language
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HRQOL in adult patients with hematologic malignancies
大体时间：After 2 years from date of registration
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To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
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After 2 years from date of registration
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Symptoms in adult patients with hematologic malignancies
大体时间：After 2 years from date of registration
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To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
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After 2 years from date of registration
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Adherence to therapy in adult patients with hematologic malignancies
大体时间：After 2 years from date of registration
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To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
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After 2 years from date of registration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of clinically relevant functional limitations and symptoms
大体时间：After 2 years from date of registration
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To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)
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After 2 years from date of registration
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Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire
大体时间：After 2 years from date of registration
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To investigate factors associated with physical and mental health concerns
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After 2 years from date of registration
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Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
大体时间：After 2 years from date of registration
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To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
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After 2 years from date of registration
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Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
大体时间：After 2 years from date of registration
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To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
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After 2 years from date of registration
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Clinical strategies adopted by physicians
大体时间：After 2 years from date of registration
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To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios
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After 2 years from date of registration
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marco Vignetti、GIMEMA Foundation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年12月2日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2024年12月1日
研究注册日期
首次提交
2020年9月30日
首先提交符合 QC 标准的
2020年10月6日
首次发布 (实际的)
2020年10月9日
研究记录更新
最后更新发布 (实际的)
2021年5月17日
上次提交的符合 QC 标准的更新
2021年5月13日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.