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

Gruppo Italiano Malattie EMatologiche dell'Adulto25 sites in 1 country572 target enrollmentMay 29, 2020

ConditionsMyeloproliferative Neoplasm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myeloproliferative Neoplasm
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Enrollment: 572
Locations: 25
Primary Endpoint: Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 29, 2020

End Date

November 15, 2025

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population

Time Frame: After 5 years from study entry

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).

Secondary Outcomes

Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population(After 5 years from study entry)
MPN patients' baseline profiles of self-reported HRQoL(After 5 years from study entry)
Prognostic value of baseline patients' self-reported fatigue(After 5 years from study entry)
Prognostic value of baseline patients' self-reported HRQoL(After 5 years from study entry)
Relationship between pruritus and HRQoL.(After 5 years from study entry)
Patterns over time of HRQoL(After 5 years from study entry)
Prognostic patient-based index(After 5 years from study entry)
Physicians' and patients' preferences for involvement in treatment decision-making(After 5 years from study entry)
Relationship between self-reported satisfaction with care with other HRQoL outcomes.(After 5 years from study entry)