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This study will ultimately aim at developing a GIMEMA platform for collecting HRQoL and symptom burden information on Italian patients with Philadelphia chromosome negative MPN. The main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Quality of life assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population | To detect a baseline difference of at least 4 points between MPN patients and their peers in the general population in any of the following primary scales of the EORTC QLQ-C30 questionnaire: fatigue, global QoL/health status, physical, emotional and role functioning (all ranging from 0 to 100 points). | After 5 years from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population | The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire. | After 5 years from study entry |
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with myeloproliferative neoplasms (MPN)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia | Alessandria | Italy | ||||
| Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia |
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The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire. |
| After 5 years from study entry |
| MPN patients' baseline profiles of self-reported HRQoL | To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores. | After 5 years from study entry |
| Prognostic value of baseline patients' self-reported fatigue | To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30 | After 5 years from study entry |
| Prognostic value of baseline patients' self-reported HRQoL | To investigate the prognostic value of baseline patients' self-reported HRQoL | After 5 years from study entry |
| Relationship between pruritus and HRQoL. | To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL. | After 5 years from study entry |
| Patterns over time of HRQoL | To estimate and compare patterns over time of HRQoL (outcome measures: EORTC QLQ-C30, FACIT-Fatigue, MPN-SAF TSS and FACIT-TS-G) of PT, EV and PMF patients. | After 5 years from study entry |
| Prognostic patient-based index | To devise a prognostic patient-based index. | After 5 years from study entry |
| Physicians' and patients' preferences for involvement in treatment decision-making | To assess physicians' and patients' preferences for involvement in treatment decision-making, as assessed by the CPS Questionnaire, across different risk groups and examine relationships between preferences for involvement and patient characteristics. | After 5 years from study entry |
| Relationship between self-reported satisfaction with care with other HRQoL outcomes. | To investigate the relationship, in MPN patients, between self-reported satisfaction with care as assessed by the FACIT-TS-G questionnaire and its relationship with other HRQoL outcomes. | After 5 years from study entry |
| Asti |
| Italy |
| Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto | Bari | Italy |
| Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia | Bari | Italy |
| Istituto di Ematologia "Lorenzo e A. Seragnoli" | Bologna | Italy |
| Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo | Cagliari | Italy |
| Aou Careggi - Firenze - Sod Ematologia | Florence | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano | Milan | Italy |
| Aou Di Modena - Sc Ematologia | Modena | Italy |
| Azienda Ospedaliera "S.Gerardo" | Monza | Italy |
| Aou Federico Ii - Napoli - Uoc Ematologia | Naples | Italy |
| .C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro | Novara | Italy |
| Aou Policlinico P. Giaccone - Palermo - Uo Ematologia | Palermo | Italy |
| Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia | Pavia | Italy |
| Aou Pisana - Uo Ematologia Universitaria | Pisa | Italy |
| Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia | Reggio Emilia | Italy |
| Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia | Rimini | Italy |
| C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia | Rionero in Vulture | Italy |
| Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia | Roma | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica | Roma | Italy |
| Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia | Roma | Italy |
| Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia | Sassari | Italy |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino | Torino | Italy |
| Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia | Torino | Italy |
| Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia | Torino | Italy |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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