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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01510873
First received: January 12, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention
Immune Thrombocytopenic Purpura
Other: HRQOL evaluation

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported fatigue amongst the three different pITP groups [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Patient-reported fatigue amongst the three different pITP groups. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • Possible association between socio-demographic and clinical variables with patient reported health outcomes. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]
  • To assess patients' preferences for involvement in treatment decision-making. [ Time Frame: By the end of the study. ] [ Designated as safety issue: No ]

Enrollment: 424
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510873

Locations
Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Italy
Azienda Sanitaria Locale BA - Ospedale di Venere
Bari, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale
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 Universitaria - Policlinico "G. Martino"
Messina, Italy
Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
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.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
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
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Fabio Efficace, PhD GIMEMA DATA CENTER, ROME, ITALY
  More Information

Additional Information:
GIMEMA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01510873     History of Changes
Other Study ID Numbers: QoL-ITP0411
Study First Received: January 12, 2012
Last Updated: January 22, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Health-related quality of life
Fatigue
pITO
Primary Immune Thrombocytopenic Purpura

Additional relevant MeSH terms:
Fatigue
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Signs and Symptoms
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on October 19, 2014