Drug Observance and Side Effects of Cytoreductive Drugs in PV and ET Patients

Polycythemia Vera Clinical Trial

— OUEST  

Official title:

Etude de l'Observance thérapeutique et Des Effets Secondaires Des Traitements Chez Les Patients traités Pour Polyglobulie de Vaquez et thrombocytémie Essentielle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893410
• Other study ID #: OUEST (RB14.115)
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential thrombocythemia completed an unique paper questionnaire in order to describe their observance, the side effects and their own appreciation of the taken drug.

Description:

During one year, all patients with PV or ET followed in our centre, and who took a drug to treat their MPN, were identified.

The investigators submitted by mail or directly at the consultation a unique questionnaire containing 25 questions concerning patients characteristics, evaluation of observance, identification of side effects and own appreciation of the drug.

After completion of the questionnaire, the patients were identified and followed to collect new data about thrombotic events or phenotypic evolution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with PV or ET or SMF

• Patients who took oral or sub-cutaneous drugs to treat their MPN.

• Patients who agreed to complete the questionnaire

Exclusion Criteria:

• Patients with low risk PV or ET who do not take treatment

• Patients unable to complete the questionnaire

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (1)

Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adherence to drug prescription	prospective evaluation in a one shot questionnaire given to each treated patient seen at the consultation distributed between december 2014 and december 2015	At inclusion