Clinical trial NCT04581187: An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies
Official title: An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Malignancies
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with any hematologic malignancy

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.


Eligibility criteria: 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

Primary outcomes:
measure: HRQOL in adult patients with hematologic malignancies
timeFrame: After 2 years from date of registration
measure: Symptoms in adult patients with hematologic malignancies
timeFrame: After 2 years from date of registration
measure: Adherence to therapy in adult patients with hematologic malignancies
timeFrame: After 2 years from date of registration
Secondary outcomes:
measure: Prevalence of clinically relevant functional limitations and symptoms
timeFrame: After 2 years from date of registration
measure: Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire
timeFrame: After 2 years from date of registration
measure: Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes
timeFrame: After 2 years from date of registration
measure: Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes
timeFrame: After 2 years from date of registration
measure: Clinical strategies adopted by physicians
timeFrame: After 2 years from date of registration
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
city: Bari
country: Italy
facility: Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
city: Bari
country: Italy
facility: Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia
city: Barletta
country: Italy
facility: Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia
city: Cagliari
country: Italy
facility: AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO
city: Catania
country: Italy
facility: Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia
city: Foggia
country: Italy
facility: Aou Ospedali Riuniti - Foggia- UOC Ematologia
city: Lecce
country: Italy
facility: Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
city: Modena
country: Italy
facility: Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia
city: Napoli
country: Italy
facility: Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia
city: Novara
country: Italy
facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara
city: Palermo
country: Italy
facility: Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
city: Palermo
country: Italy
facility: Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica
city: Pescara
country: Italy
facility: Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
city: Reggio Emilia
country: Italy
facility: Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia
city: Roma
country: Italy
facility: Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali
city: Roma
country: Italy
facility: AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
city: Roma
country: Italy
facility: Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
city: Roma
country: Italy
facility: Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
city: Roma
country: Italy
facility: Divisione di Ematologia - Ospedale S. Eugenio
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
city: San Giovanni Rotondo
country: Italy
facility: Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
city: Sassari
country: Italy
facility: Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
city: Sassuolo
country: Italy
facility: Ospedale Di Sassuolo Spa - Ematologia
city: Torino
country: Italy
facility: Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
city: Torino
country: Italy
facility: Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Study officials:
affiliation: GIMEMA Foundation
name: Marco Vignetti
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.