Clinical trial NCT01510873: Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
Official title: Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenic Purpura
Keywords: Health-related quality of life
Fatigue
pITO
Primary Immune Thrombocytopenic Purpura
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease

Brief summary: 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.

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 criteria: 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.

Primary outcomes:
measure: Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
timeFrame: By the end of the study.
Secondary outcomes:
measure: Patient-reported fatigue amongst the three different pITP groups
timeFrame: By the end of the study.
measure: Patient-reported fatigue amongst the three different pITP groups.
timeFrame: By the end of the study.
measure: Possible association between socio-demographic and clinical variables with patient reported health outcomes.
timeFrame: By the end of the study.
measure: To assess patients' preferences for involvement in treatment decision-making.
timeFrame: By the end of the study.
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Consorziale
city: Bari
country: Italy
facility: Azienda Sanitaria Locale BA - Ospedale di Venere
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Cagliari
country: Italy
facility: Ospedale Binaghi
city: Cagliari
country: Italy
facility: Ospedale Businco
city: Campobasso
country: Italy
facility: U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
city: Castelfranco Veneto
country: Italy
facility: US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Genova
country: Italy
facility: DIMI- Clinica Ematologica - Università degli studi di Genova
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico "G. Martino"
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena
city: Monza
country: Italy
facility: Azienda Ospedaliera "S. Gerardo dei Tintori"
city: Novara
country: Italy
facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
city: Orbassano
country: Italy
facility: Ospedale S. Luigi Gonzaga
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
city: Parma
country: Italy
facility: Azienda Ospedaliero - Universitaria di Parma
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
city: Roma
country: Italy
facility: U.O.C. Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
city: Rome
country: Italy
facility: UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
city: Siena
country: Italy
facility: U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: Azienda Ospedaliero - Universitaria "San Giovanni Battista"
city: Treviglio
country: Italy
facility: Azienda Ospedaliera
city: Vicenza
country: Italy
facility: ULSS N.6 Ospedale San Bortolo
Study officials:
affiliation: GIMEMA DATA CENTER, ROME, ITALY
name: Fabio Efficace, PhD
role: PRINCIPAL_INVESTIGATOR
References: