Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Immune Thrombocytopenic Purpura |
Other: HRQOL evaluation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP). |
- Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Patient-reported fatigue amongst the three different pITP groups [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Patient-reported fatigue amongst the three different pITP groups. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
- To assess patients' preferences for involvement in treatment decision-making. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
| Enrollment: | 424 |
| Study Start Date: | December 2011 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Newly Diagnosed pITP
Patients within 3 months from diagnosis.
|
Other: HRQOL evaluation
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. |
|
Persistent pITP
Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy.
|
Other: HRQOL evaluation
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. |
|
Chronic pITP
Patients with ITP lasting for more than 12 months.
|
Other: HRQOL evaluation
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. |
Detailed Description:
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:
- Patient-reported fatigue amongst the three different pITP groups.
- Social support and psychological wellbeing as a possible determinant of HRQOL.
- Possible association between socio-demographic (e.g., age, living arrangements, education and employment status) and clinical variables (e.g., time from diagnosis, and current treatment if any) with patient reported health outcomes (e.g., HRQOL, fatigue, and social support).
- To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics and to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians (only for Newly Diagnosed pITP).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease
Inclusion Criteria:
- A confirmed diagnosis of pITP in any phase of the disease;
- Patients aged at least 18 years;
- Informed consent provided
Exclusion Criteria:
- Participating in other HRQOL investigations that might interfere with this study
- Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01510873
| Italy | |
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni Rotondo, Foggia, Italy | |
| 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 | |
| DIMI- Clinica Ematologica - Università degli studi di Genova | |
| Genova, Italy | |
| Azienda Ospedaliera Universitaria San Martino | |
| 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.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita | |
| Roma, Italy | |
| U.O.C. Ematologia - Ospedale S.Eugenio | |
| 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 | |
| Principal Investigator: | Fabio Efficace, PhD | GIMEMA DATA CENTER, ROME, ITALY |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT01510873 History of Changes |
| Other Study ID Numbers: | QoL-ITP0411 |
| Study First Received: | January 12, 2012 |
| Last Updated: | January 22, 2014 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
Health-related quality of life Fatigue pITO Primary Immune Thrombocytopenic Purpura |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Hematologic Diseases Hemorrhage |
Hemorrhagic Disorders Immune System Diseases Pathologic Processes Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies |
ClinicalTrials.gov processed this record on March 01, 2015