- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510873
Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP).
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Acquaviva delle Fonti, Italy
- Ospedale Generale Regionale "F. Miulli"
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Bari, Italy
- Azienda Ospedaliero-Universitaria Policlinico Consorziale
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Bari, Italy
- Azienda Sanitaria Locale BA - Ospedale di Venere
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Bergamo, Italy
- Ospedali Riuniti di Bergamo
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Cagliari, Italy
- Ospedale Businco
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Cagliari, Italy
- Ospedale Binaghi
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Campobasso, Italy
- U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
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Castelfranco Veneto, Italy
- US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
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Foggia, Italy
- Azienda Ospedaliero Universitaria
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Genova, Italy
- Azienda Ospedaliera Universitaria San Martino
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Genova, Italy
- DIMI- Clinica Ematologica - Università degli studi di Genova
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Latina, Italy
- Ospedale Santa Maria Goretti
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Messina, Italy
- Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
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Messina, Italy
- Azienda Ospedaliera Universitaria - Policlinico "G. Martino"
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Modena, Italy
- Azienda Ospedaliero - Universitaria di Modena
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Monza, Italy
- Azienda Ospedaliera "S. Gerardo dei Tintori"
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Novara, Italy
- S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
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Orbassano, Italy
- Ospedale S. Luigi Gonzaga
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Palermo, Italy
- Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
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Parma, Italy
- Azienda Ospedaliero - Universitaria di Parma
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Reggio Calabria, Italy
- Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
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Roma, Italy
- U.O.C. Ematologia - Ospedale S.Eugenio
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Roma, Italy
- U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
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Rome, Italy
- UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
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Siena, Italy
- U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
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Torino, Italy
- Azienda Ospedaliero - Universitaria "San Giovanni Battista"
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Treviglio, Italy
- Azienda Ospedaliera
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Vicenza, Italy
- ULSS N.6 Ospedale San Bortolo
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Foggia
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San Giovanni Rotondo, Foggia, Italy
- Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Newly Diagnosed pITP
Patients within 3 months from diagnosis.
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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.
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Time Frame: By the end of the study.
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By the end of the study.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient-reported fatigue amongst the three different pITP groups
Time Frame: By the end of the study.
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By the end of the study.
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Patient-reported fatigue amongst the three different pITP groups.
Time Frame: By the end of the study.
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By the end of the study.
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Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Time Frame: By the end of the study.
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By the end of the study.
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To assess patients' preferences for involvement in treatment decision-making.
Time Frame: By the end of the study.
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By the end of the study.
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Fatigue
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- QoL-ITP0411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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