Immune Thrombocytopenic PurpuraNCT01510873
Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
An observational study of Immune Thrombocytopenic Purpura, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 29 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- HRQOL evaluation
- How many people
- 424 participants
- Where
- 29 sitesItaly
- Study dates
- Dec 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease
Who may be able to join
- A confirmed diagnosis of pITP in any phase of the disease;
- Patients aged at least 18 years;
- Informed consent provided
Who cannot join
- Participating in other HRQOL investigations that might interfere with this study
- Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Italy29 sites
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti
Azienda Ospedaliero-Universitaria Policlinico Consorziale
Bari
Azienda Sanitaria Locale BA - Ospedale di Venere
Bari
Ospedali Riuniti di Bergamo
Bergamo
Ospedale Binaghi
Cagliari
Ospedale Businco
Cagliari
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Campobasso
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto
Azienda Ospedaliero Universitaria
Foggia
Azienda Ospedaliera Universitaria San Martino
Genova
DIMI- Clinica Ematologica - Università degli studi di Genova
Genova
Ospedale Santa Maria Goretti
Latina
Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina
Azienda Ospedaliera Universitaria - Policlinico "G. Martino"
Messina
Azienda Ospedaliero - Universitaria di Modena
Modena
Azienda Ospedaliera "S. Gerardo dei Tintori"
Monza
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Ospedale S. Luigi Gonzaga
Orbassano
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo
Azienda Ospedaliero - Universitaria di Parma
Parma
Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
Reggio Calabria
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
Roma
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Rome
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena
Azienda Ospedaliero - Universitaria "San Giovanni Battista"
Torino
Azienda Ospedaliera
Treviglio
ULSS N.6 Ospedale San Bortolo
Vicenza
About this study
Official title: 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.
Read the 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
- Being tested
- HRQOL evaluation
- Keywords
- Health-related quality of life, Fatigue, pITO, Primary Immune Thrombocytopenic Purpura
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRQOL evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed pITP | Patients within 3 months from diagnosis. Receives: Other: HRQOL evaluation | |
| Persistent pITP | Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy. Receives: Other: HRQOL evaluation | |
| Chronic pITP | Patients with ITP lasting for more than 12 months. Receives: Other: HRQOL evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Measured: By the end of the study.
Secondary outcomes (4)
Patient-reported fatigue amongst the three different pITP groups
Measured: By the end of the study.
Patient-reported fatigue amongst the three different pITP groups.
Measured: By the end of the study.
Possible association between socio-demographic and clinical variables with patient reported health outcomes.
Measured: By the end of the study.
To assess patients' preferences for involvement in treatment decision-making.
Measured: By the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Efficace, PhD, Principal investigator, GIMEMA DATA CENTER, ROME, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510873
- Sponsor's protocol ID
- QoL-ITP0411
- Status last verified
- Jan 2014
- First submitted
- 12 Jan 2012
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP).
- ClinicalTrials.gov ID
- NCT01510873
- Acronym / sponsor ID
- QoL-ITP0411
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- Health-related quality of life, Fatigue, pITO, Primary Immune Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed pITP | – | Other: HRQOL evaluationPatients within 3 months from diagnosis. |
| Persistent pITP | – | Other: HRQOL evaluationPatients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy. |
| Chronic pITP | – | Other: HRQOL evaluationPatients with ITP lasting for more than 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease
Key inclusion criteria (3 listed)
- A confirmed diagnosis of pITP in any phase of the disease;
- Patients aged at least 18 years;
- Informed consent provided
Key exclusion criteria (2 listed)
- Participating in other HRQOL investigations that might interfere with this study
- Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRQOL evaluationPatients 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. | Other | Chronic pITP, Newly Diagnosed pITP, Persistent pITP |
Primary outcome
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Time frame: By the end of the study.
4 secondary outcomes
Patient-reported fatigue amongst the three different pITP groups
Time frame: By the end of the study.
Patient-reported fatigue amongst the three different pITP groups.
Time frame: 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.
To assess patients' preferences for involvement in treatment decision-making.
Time frame: By the end of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
- GIMEMALink provided by the sponsor.
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RecruitingPhase 2
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Efficace, PhD principal investigator
GIMEMA DATA CENTER, ROME, ITALY
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenic Purpura, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 29 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group. (time frame: By the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.