An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies

Hematologic Malignancies Clinical Trial

Official title:

An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581187
• Other study ID #: GIMEMA-ALLIANCE Platform
• Status: Recruiting
• Start date: December 2, 2020
• Est. completion date: December 2024

Study information

• Verified date: May 2021
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Fabio Efficace
• Phone: +39 06441639831
• Email: alliance[@]gimema.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• Quality of life assessment
Quality of life questionnaires

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Prevalence of clinically relevant functional limitations and symptoms	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)	After 2 years from date of registration
Secondary	Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire	To investigate factors associated with physical and mental health concerns	After 2 years from date of registration
Secondary	Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes	To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes	After 2 years from date of registration
Secondary	Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes	To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes	After 2 years from date of registration
Secondary	Clinical strategies adopted by physicians	To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios	After 2 years from date of registration