Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
- Conditions
- Adherence, PatientAdherence, Treatment
- Registration Number
- NCT06078319
- Brief Summary
The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.
- Detailed Description
The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
- Age ≥ 18 years
- Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia Vera or diagnosed with Polycythemia Vera who are in the treatment with ruxolitinib therapy in accordance with normal clinical practice
- Obtaining informed consent for data collection and processing
- The Patient must come to the in-person visit at least once, an occasion on which informed consent to 'study membership will be offered
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence 2 years Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
Distress 2 years Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress (minimum value: 0, lower distress; maximum value: 10, higher distress)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Azienda Ospedaliera Annunziata
🇮🇹Cosenza, Calabria, Italy
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
🇮🇹Genova, Liguria, Italy
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
🇮🇹Roma, Lazio, Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
🇮🇹Reggio Calabria, Calabria, Italy
A.O.U. Integrata Verona - Borgo Roma
🇮🇹Verona, Veneto, Italy
AOU di Padova
🇮🇹Padova, Veneto, Italy
Ospedale Belcolle
🇮🇹Viterbo, Lazio, Italy
A.O.U. Integrata di Udine
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo
🇮🇹Napoli, Campania, Italy
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
🇮🇹Ferrara, Emilia-Romagna, Italy
AUSL di Piacenza - Palazzine Medicine Specialistiche
🇮🇹Piacenza, Emilia-Romagna, Italy
IRCCS Policlinico Sant'Orsola
🇮🇹Bologna, Emilia Romagna, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Emilia-Romagna, Italy
Dipartimento Oncoematologico - AUSL della Romagna
🇮🇹Ravenna, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova - IRCCS
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Ospedale Infermi di Rimini
🇮🇹Rimini, Emilia-Romagna, Italy
Ospedale S. Eugenio
🇮🇹Roma, Lazio, Italy
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Ospedale San Gerardo
🇮🇹Monza, Lombardia, Italy
Department of Oncology, University of Torino
🇮🇹Torino, Piemonte, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
🇮🇹Pesaro, Marche, Italy
Ospedale San Luigi Gonzaga
🇮🇹Orbassano, Piemonte, Italy
A. O. Ordine Mauriziano di Torino
🇮🇹Torino, Piemonte, Italy
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
🇮🇹Cagliari, Sardegna, Italy
A.O.U. Città della Salute e della Scienza - Presidio Molinette
🇮🇹Torino, Piemonte, Italy
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
🇮🇹Catania, Sicilia, Italy
Policlinico S.Maria alle Scotte
🇮🇹Siena, Toscana, Italy