Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising, menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with pITP. The investigators project will aim at providing scientific community solid evidence based data on the extent to which HRQOL is compromised and in which specific area.
The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL) profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a matched Italian population control Group.
OBJECTIVES:
The primary objective is to compare HRQOL of patients with pITP with that of a matched Italian population control Group.
Secondary objectives include evaluation of:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly Diagnosed pITP | Patients within 3 months from diagnosis. |
| |
| Persistent pITP | Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy. |
| |
| Chronic pITP | Patients with ITP lasting for more than 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRQOL evaluation | Other | Patients will be asked to complete a Questionnaire (i.e. HRQOL Survey Packet) that will cover a number of issues. These will include socio-demographic aspects, HRQOL information, symptom burden, clinical decision-making, social support and psychological wellbeing. Most of these information will be collected through well known psychometrically sound questionnaires. The copyright for using standardized questionnaires will be obtained, from the appropriate copyright holders, for the purpose of this research. The Questionnaire properly formatted will be distributed to all participating Centers prior to study start. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group. | By the end of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported fatigue amongst the three different pITP groups | By the end of the study. | |
| Patient-reported fatigue amongst the three different pITP groups. | By the end of the study. | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabio Efficace, PhD | GIMEMA DATA CENTER, ROME, ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | Italy | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2017 | |
| Reset | Aug 24, 2018 | |
| Release | Oct 12, 2018 |
Not provided
Not provided
Not provided
Not provided
|
| Possible association between socio-demographic and clinical variables with patient reported health outcomes. |
| By the end of the study. |
| To assess patients' preferences for involvement in treatment decision-making. | By the end of the study. |
| Ospedale Generale Regionale "F. Miulli" |
| Acquaviva delle Fonti |
| Italy |
| Azienda Ospedaliero-Universitaria Policlinico Consorziale | Bari | Italy |
| Azienda Sanitaria Locale BA - Ospedale di Venere | Bari | Italy |
| Ospedali Riuniti di Bergamo | Bergamo | Italy |
| Ospedale Binaghi | Cagliari | Italy |
| Ospedale Businco | Cagliari | Italy |
| U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche | Campobasso | Italy |
| US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo | Castelfranco Veneto | Italy |
| Azienda Ospedaliero Universitaria | Foggia | Italy |
| Azienda Ospedaliera Universitaria San Martino | Genova | Italy |
| DIMI- Clinica Ematologica - Università degli studi di Genova | Genova | Italy |
| Ospedale Santa Maria Goretti | Latina | Italy |
| Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" | Messina | Italy |
| Azienda Ospedaliera Universitaria - Policlinico "G. Martino" | Messina | Italy |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy |
| Azienda Ospedaliera "S. Gerardo dei Tintori" | Monza | Italy |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara | Italy |
| Ospedale S. Luigi Gonzaga | Orbassano | Italy |
| Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone | Palermo | Italy |
| Azienda Ospedaliero - Universitaria di Parma | Parma | Italy |
| Azienda Ospedaliera "Bianchi - Melacrino - Morelli" | Reggio Calabria | Italy |
| U.O.C. Ematologia - Ospedale S.Eugenio | Roma | Italy |
| U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita | Roma | Italy |
| UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza" | Rome | Italy |
| U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | Siena | Italy |
| Azienda Ospedaliero - Universitaria "San Giovanni Battista" | Torino | Italy |
| Azienda Ospedaliera | Treviglio | Italy |
| ULSS N.6 Ospedale San Bortolo | Vicenza | Italy |
| Reset | Feb 19, 2019 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2017 | Aug 24, 2018 | |||
| Oct 12, 2018 | Feb 19, 2019 |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided