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NCT Number: NCT04378855

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myeloproliferative Neoplasm Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia, Alessandria, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire

Other

Quality of life assessment

Primary outcomes

  1. 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

  1. 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

    The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire.

  2. 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

    The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire.

  3. MPN patients' baseline profiles of self-reported HRQoL

    Time frame: After 5 years from study entry

    To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores.

  4. Prognostic value of baseline patients' self-reported fatigue

    Time frame: After 5 years from study entry

    To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30

  5. Prognostic value of baseline patients' self-reported HRQoL

    Time frame: After 5 years from study entry

    To investigate the prognostic value of baseline patients' self-reported HRQoL

  6. Relationship between pruritus and HRQoL.

    Time frame: After 5 years from study entry

    To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL.

  7. Patterns over time of HRQoL

    Time frame: 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.

  8. Prognostic patient-based index

    Time frame: After 5 years from study entry

    To devise a prognostic patient-based index.

  9. Physicians' and patients' preferences for involvement in treatment decision-making

    Time frame: 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.

  10. Relationship between self-reported satisfaction with care with other HRQoL outcomes.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Acronym: PROPHECY

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
May 7, 2020
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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