Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Completed

• Conditions: Adherence, Patient; Adherence, Treatment

• Registration Number: NCT06078319
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2021-01-18
• Status Verified: 2023-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

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)

Trial Locations

Locations (28)

Azienda Ospedaliera Annunziata; 🇮🇹 Cosenza, Calabria, Italy

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"; 🇮🇹 Reggio Calabria, Calabria, Italy

Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo; 🇮🇹 Napoli, Campania, Italy

IRCCS Policlinico Sant'Orsola; 🇮🇹 Bologna, Emilia Romagna, Italy

Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna; 🇮🇹 Ferrara, Emilia-Romagna, Italy

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, Emilia-Romagna, Italy

AUSL di Piacenza - Palazzine Medicine Specialistiche; 🇮🇹 Piacenza, 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

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