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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life assessment | Other | Quality of life questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with any hematologic malignancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Efficace | Contact | +39 06441639831 | alliance@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Vignetti | GIMEMA Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona | Not yet recruiting | Ancona | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33890580 | Derived | 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. |
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| 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 |
| 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 |
| 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 |
| 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 |
| Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari |
| Not yet recruiting |
| Aviano |
| Italy |
| Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto | Not yet recruiting | Bari | Italy |
| Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia | Recruiting | Bari | Italy |
| Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia | Not yet recruiting | Barletta | Italy |
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| AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO | Recruiting | Cagliari | Italy |
| Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia | Not yet recruiting | Catania | Italy |
| Aou Ospedali Riuniti - Foggia- UOC Ematologia | Recruiting | Foggia | Italy |
| Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia | Recruiting | Lecce | Italy |
| Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia | Recruiting | Modena | Italy |
| Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia | Recruiting | Naples | Italy |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara | Recruiting | Novara | Italy |
| Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo | Recruiting | Palermo | Italy |
| Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica | Recruiting | Palermo | Italy |
| Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica | Not yet recruiting | Pescara | Italy |
| Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia | Recruiting | Reggio Emilia | Italy |
| Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali | Recruiting | Roma | Italy |
| AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali | Not yet recruiting | Roma | Italy |
| Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia | Recruiting | Roma | Italy |
| Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia | Recruiting | Roma | Italy |
| Divisione di Ematologia - Ospedale S. Eugenio | Recruiting | Roma | Italy |
| Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali | Recruiting | Roma | Italy |
| Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia | Recruiting | San Giovanni Rotondo | Italy |
| Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia | Recruiting | Sassari | Italy |
| Ospedale Di Sassuolo Spa - Ematologia | Not yet recruiting | Sassuolo | Italy |
| Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia | Recruiting | 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 | Not yet recruiting | Torino | Italy |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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