Myeloproliferative Neoplasm
Conditions
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.
Interventions
OTHERQuestionnaire
Quality of life assessment
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 EORTC QLQ-C30 questionnaire. |
| 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. |
| Prognostic value 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 |
| 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. |
| 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. |
| 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. |
| Prognostic value of baseline patients' self-reported HRQoL | After 5 years from study entry | To investigate the prognostic value of baseline patients' self-reported HRQoL |
Countries
Italy
Outcome results
None listed