Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).

Study Overview
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Brief Summary
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This study will ultimately aim at developing a GIMEMA platform for collecting HRQoL and symptom burden information on Italian patients with Philadelphia chromosome negative MPN. The main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.

Official Title
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Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients

Conditions
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Myeloproliferative Neoplasm

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (pre-PMF, overt-PMF) and post-ET/post-PV Myelofibrosis (MF), (i.e. Philadelphia chromosome negative myeloproliferative neoplasm (MPN)) according to 2016 WHO classification. Known IPSS/IPSET/DIPSS risk score category at time of initial diagnosis of PV, ET and PMF, respectively. Initial diagnosis of MPN within one year before date of registration. Having a full baseline PRO Evaluation completed. Adult patients (≥ 18 years old). Written informed consent provided. Exclusion Criteria: Having any kind of psychiatric disorder or major cognitive dysfunction problems hampering a self-reported evaluation. Not able to read and understand local language (i.e. Italian).

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

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Quality of life assessment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population | To detect a baseline difference of at least 4 points between MPN patients and their peers in the general population in any of the following primary scales of the EORTC QLQ-C30 questionnaire: fatigue, global QoL/health status, physical, emotional and role functioning (all ranging from 0 to 100 points). | After 5 years from study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population | The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire. | After 5 years from study entry | 
| Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population | The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire. | After 5 years from study entry | 
| MPN patients' baseline profiles of self-reported HRQoL | To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores. | After 5 years from study entry | 
| Prognostic value, on overall survival and other clinical outcomes, of baseline patients' self-reported fatigue | To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30 | After 5 years from study entry | 
| Prognostic value, on overall survival and other clinical outcomes, of baseline patients' self-reported HRQoL | To investigate the prognostic value of baseline patients' self-reported HRQoL | After 5 years from study entry | 
| Relationship between pruritus and HRQoL. | To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL. | After 5 years from study entry | 
| Patterns over time of HRQoL | To estimate and compare patterns over time of HRQoL (outcome measures: EORTC QLQ-C30, FACIT-Fatigue, MPN-SAF TSS and FACIT-TS-G) of PT, EV and PMF patients. | After 5 years from study entry | 
| Prognostic patient-based index | To devise a prognostic patient-based index. | After 5 years from study entry | 
| Physicians' and patients' preferences for involvement in treatment decision-making | To assess physicians' and patients' preferences for involvement in treatment decision-making, as assessed by the CPS Questionnaire, across different risk groups and examine relationships between preferences for involvement and patient characteristics. | After 5 years from study entry | 
| Relationship between self-reported satisfaction with care with other HRQoL outcomes. | To investigate the relationship, in MPN patients, between self-reported satisfaction with care as assessed by the FACIT-TS-G questionnaire and its relationship with other HRQoL outcomes. | After 5 years from study entry |