Clinical trial NCT06078319: Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Official title: Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence, Patient
Adherence, Treatment
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary MF or secondary to Essential Thrombocythemia/PV or diagnosed with PV, aged 18 years or older.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Adherence
timeFrame: 2 years
measure: Distress
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: Azienda Ospedaliera Annunziata
state: Calabria
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
state: Calabria
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo
state: Campania
city: Bologna
country: Italy
facility: IRCCS Policlinico Sant'Orsola
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
state: Emilia-Romagna
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: AUSL di Piacenza - Palazzine Medicine Specialistiche
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Dipartimento Oncoematologico - AUSL della Romagna
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O.U. Integrata di Udine
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Ospedale S. Eugenio
state: Lazio
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
state: Lazio
city: Viterbo
country: Italy
facility: Ospedale Belcolle
state: Lazio
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
state: Liguria
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Lombardia
city: Pesaro
country: Italy
facility: A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
state: Marche
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga
state: Piemonte
city: Torino
country: Italy
facility: Department of Oncology, University of Torino
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza - Presidio Molinette
state: Piemonte
city: Torino
country: Italy
facility: A. O. Ordine Mauriziano di Torino
state: Piemonte
city: Cagliari
country: Italy
facility: Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
state: Sardegna
city: Catania
country: Italy
facility: A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
state: Sicilia
city: Siena
country: Italy
facility: Policlinico S.Maria alle Scotte
state: Toscana
city: Padova
country: Italy
facility: AOU di Padova
state: Veneto
city: Verona
country: Italy
facility: A.O.U. Integrata Verona - Borgo Roma
state: Veneto
Study officials:
References: