An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies
An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
1 other identifier
observational
400
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 17, 2021
May 1, 2021
2 years
September 30, 2020
May 13, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
HRQOL in adult patients with hematologic malignancies
To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
After 2 years from date of registration
Symptoms in adult patients with hematologic malignancies
To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
After 2 years from date of registration
Adherence to therapy in adult patients with hematologic malignancies
To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)
After 2 years from date of registration
Secondary Outcomes (5)
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
Clinical strategies adopted by physicians
After 2 years from date of registration
Interventions
Quality of life questionnaires
Eligibility Criteria
Adult patients diagnosed with any hematologic malignancy
You may qualify if:
- Diagnosis of any hematologic malignancy according to 2016 WHO classification
- Adult Patients (≥18 years).
- Written informed consent
You may not qualify if:
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
- Not able to read and understand local language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona
Ancona, Italy
Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
Aviano, Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia
Bari, Italy
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia
Barletta, Italy
AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO
Cagliari, Italy
Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia
Catania, Italy
Aou Ospedali Riuniti - Foggia- UOC Ematologia
Foggia, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, Italy
Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia
Modena, Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia
Napoli, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara
Novara, Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, Italy
Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica
Palermo, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, Italy
Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia
Reggio Emilia, Italy
Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali
Roma, Italy
AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
Roma, Italy
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
Roma, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Divisione di Ematologia - Ospedale S. Eugenio
Roma, Italy
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Ospedale Di Sassuolo Spa - Ematologia
Sassuolo, Italy
Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
Torino, Italy
Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, Italy
Related Publications (1)
Efficace F, Breccia M, Fazi P, Cottone F, Holzner B, Vignetti M. The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study. JMIR Res Protoc. 2021 Jun 1;10(6):e25271. doi: 10.2196/25271.
PMID: 33890580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Vignetti
GIMEMA Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 9, 2020
Study Start
December 2, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2024
Last Updated
May 17, 2021
Record last verified: 2021-05