Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)

Completed

• Conditions: Immune Thrombocytopenic Purpura
• Interventions: Other: HRQOL evaluation

• Registration Number: NCT01510873
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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).

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newly Diagnosed pITP	HRQOL evaluation	Patients within 3 months from diagnosis.
Persistent pITP	HRQOL evaluation	Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy.
Chronic pITP	HRQOL evaluation	Patients with ITP lasting for more than 12 months.

Primary Outcome Measures

Name	Time	Method
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.	By the end of the study.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (29)

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Ospedale Santa Maria Goretti; 🇮🇹 Latina, Italy

Azienda Ospedaliero-Universitaria Policlinico Consorziale; 🇮🇹 Bari, Italy

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

U.O.C. Ematologia - Ospedale S.Eugenio; 🇮🇹 Roma, Italy

Azienda Sanitaria Locale BA - Ospedale di Venere; 🇮🇹 Bari, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ospedale Generale Regionale "F. Miulli"; 🇮🇹 Acquaviva delle Fonti, Italy

Azienda Ospedaliero - Universitaria di Modena; 🇮🇹 Modena, Italy

US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo; 🇮🇹 Castelfranco Veneto, Italy

DIMI- Clinica Ematologica - Università degli studi di Genova; 🇮🇹 Genova, Italy

Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"; 🇮🇹 Messina, Italy

Azienda Ospedaliera "S. Gerardo dei Tintori"; 🇮🇹 Monza, Italy

Azienda Ospedaliera Universitaria San Martino; 🇮🇹 Genova, Italy

Azienda Ospedaliera Universitaria - Policlinico "G. Martino"; 🇮🇹 Messina, Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro; 🇮🇹 Novara, Italy

U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita; 🇮🇹 Roma, Italy

Azienda Ospedaliero Universitaria; 🇮🇹 Foggia, Italy

Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone; 🇮🇹 Palermo, Italy

Azienda Ospedaliero - Universitaria di Parma; 🇮🇹 Parma, Italy

Azienda Ospedaliero - Universitaria "San Giovanni Battista"; 🇮🇹 Torino, Italy

ULSS N.6 Ospedale San Bortolo; 🇮🇹 Vicenza, Italy

Ospedale S. Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Azienda Ospedaliera "Bianchi - Melacrino - Morelli"; 🇮🇹 Reggio Calabria, Italy

Azienda Ospedaliera; 🇮🇹 Treviglio, Italy

U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche; 🇮🇹 Campobasso, Italy

Ospedale Businco; 🇮🇹 Cagliari, Italy

Ospedale Binaghi; 🇮🇹 Cagliari, Italy

UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"; 🇮🇹 Rome, Italy