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

January 22, 2014 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

424

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Time Frame: By the end of the study.
By the end of the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reported fatigue amongst the three different pITP groups
Time Frame: By the end of the study.
By the end of the study.
Patient-reported fatigue amongst the three different pITP groups.
Time Frame: By the end of the study.
By the end of the study.
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Time Frame: By the end of the study.
By the end of the study.
To assess patients' preferences for involvement in treatment decision-making.
Time Frame: By the end of the study.
By the end of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (ESTIMATE)

January 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL-ITP0411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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