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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Completed

CT.gov ID

NCT01510873

Collaborator

(none)

424

Enrollment

Locations

Duration (Months)

14.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenic Purpura	Other: HRQOL evaluation

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 Design

Study Type:

Observational

Actual Enrollment :

424 participants

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).

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Chronic pITP

Patients with ITP lasting for more than 12 months.

Other: HRQOL evaluation

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Locations

Locations

	Site	City	State	Country
1	Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia	Italy
2	Ospedale Generale Regionale "F. Miulli"	Acquaviva delle Fonti		Italy
3	Azienda Ospedaliero-Universitaria Policlinico Consorziale	Bari		Italy
4	Azienda Sanitaria Locale BA - Ospedale di Venere	Bari		Italy
5	Ospedali Riuniti di Bergamo	Bergamo		Italy
6	Ospedale Binaghi	Cagliari		Italy
7	Ospedale Businco	Cagliari		Italy
8	U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche	Campobasso		Italy
9	US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo	Castelfranco Veneto		Italy
10	Azienda Ospedaliero Universitaria	Foggia		Italy
11	Azienda Ospedaliera Universitaria San Martino	Genova		Italy
12	DIMI- Clinica Ematologica - Università degli studi di Genova	Genova		Italy
13	Ospedale Santa Maria Goretti	Latina		Italy
14	Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"	Messina		Italy
15	Azienda Ospedaliera Universitaria - Policlinico "G. Martino"	Messina		Italy
16	Azienda Ospedaliero - Universitaria di Modena	Modena		Italy
17	Azienda Ospedaliera "S. Gerardo dei Tintori"	Monza		Italy
18	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara		Italy
19	Ospedale S. Luigi Gonzaga	Orbassano		Italy
20	Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone	Palermo		Italy
21	Azienda Ospedaliero - Universitaria di Parma	Parma		Italy
22	Azienda Ospedaliera "Bianchi - Melacrino - Morelli"	Reggio Calabria		Italy
23	U.O.C. Ematologia - Ospedale S.Eugenio	Roma		Italy
24	U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita	Roma		Italy
25	UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"	Rome		Italy
26	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena		Italy
27	Azienda Ospedaliero - Universitaria "San Giovanni Battista"	Torino		Italy
28	Azienda Ospedaliera	Treviglio		Italy
29	ULSS N.6 Ospedale San Bortolo	Vicenza		Italy