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

NCT ID: NCT01510873

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 424 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-01-31

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).

Conditions

Immune Thrombocytopenic Purpura

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Newly Diagnosed pITP

Patients within 3 months from diagnosis.

HRQOL evaluation

Intervention Type: 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.

Persistent pITP

Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy.

HRQOL evaluation

Intervention Type: 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.

Chronic pITP

Patients with ITP lasting for more than 12 months.

HRQOL evaluation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Efficace, PhD

Role: PRINCIPAL_INVESTIGATOR

GIMEMA DATA CENTER, ROME, ITALY

Locations

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

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

Countries

Italy

Related Links

http://www.gimema.it

GIMEMA

Other Identifiers

QoL-ITP0411

Identifier Type: -

Identifier Source: org_study_id