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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Immune Thrombocytopenic Purpura

Intervention / Treatment
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* Other: HRQOL evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly Diagnosed pITP<br>Patients within 3 months from diagnosis. | Other: HRQOL evaluation<br>* 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.<br>|
| Persistent pITP<br>Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy. | Other: HRQOL evaluation<br>* 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.<br>|
| Chronic pITP<br>Patients with ITP lasting for more than 12 months. | Other: HRQOL evaluation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health-related quality of life, Fatigue, pITO, Primary Immune Thrombocytopenic Purpura