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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloproliferative Neoplasm
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 576

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with myeloproliferative neoplasms (MPN)

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2025

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Neoplasms; Myeloproliferative Disorders
• Other Study ID Numbers: GIMEMA QoL-MPN 0118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No