Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).
- Conditions
- Myeloproliferative Neoplasm
- Registration Number
- NCT04378855
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 576
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population 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 Outcome Measures
Name Time Method Prognostic value, on overall survival and other clinical outcomes, of baseline patients' self-reported HRQoL After 5 years from study entry To investigate the prognostic value of baseline patients' self-reported HRQoL
Relationship between pruritus and HRQoL. After 5 years from study entry To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL.
Prognostic patient-based index After 5 years from study entry To devise a prognostic patient-based index.
Relationship between self-reported satisfaction with care with other HRQoL outcomes. After 5 years from study entry 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.
MPN patients' baseline profiles of self-reported HRQoL After 5 years from study entry To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores.
Physicians' and patients' preferences for involvement in treatment decision-making After 5 years from study entry 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.
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population After 5 years from study entry The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire.
Prognostic value, on overall survival and other clinical outcomes, of baseline patients' self-reported fatigue After 5 years from study entry To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30
Patterns over time of HRQoL After 5 years from study entry 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.