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

Recruiting

• Conditions: Hematologic Malignancies

• Registration Number: NCT04581187
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-09
• Study Start: 2020-12-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HRQOL in adult patients with hematologic malignancies	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	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	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)

Secondary Outcome Measures

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

Trial Locations

Locations (27)

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona; 🇮🇹 Ancona, Italy

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto; 🇮🇹 Bari, Italy

Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari; 🇮🇹 Aviano, Italy

Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia; 🇮🇹 Bari, Italy

AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO; 🇮🇹 Cagliari, 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 Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo; 🇮🇹 Palermo, Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara; 🇮🇹 Novara, Italy

Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia; 🇮🇹 Napoli, 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

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

Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia; 🇮🇹 Torino, Italy

Ospedale Di Sassuolo Spa - Ematologia; 🇮🇹 Sassuolo, 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

Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia; 🇮🇹 Barletta, Italy

Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia; 🇮🇹 Catania, Italy

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia; 🇮🇹 Roma, Italy