Clinical trial NCT04378855: Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).
Official title: Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myeloproliferative Neoplasm
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with myeloproliferative neoplasms (MPN)

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.


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).

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