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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT02893410
Collaborator
(none)
286
Enrollment
1
Location
12
Actual Duration (Months)
23.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    286 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Etude de l'Observance thérapeutique et Des Effets Secondaires Des Traitements Chez Les Patients traités Pour Polyglobulie de Vaquez et thrombocytémie Essentielle
    Actual Study Start Date :
    Dec 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Rate of adherence to drug prescription [At inclusion]

      prospective evaluation in a one shot questionnaire given to each treated patient seen at the consultation distributed between december 2014 and december 2015

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Study Director: Jean-Christophe Ianotto, MD, CHRU de Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT02893410
    Other Study ID Numbers:
    • OUEST (RB14.115)
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Sep 21, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Polycythemia Vera
    Polycythemia
    Thrombocytosis
    Thrombocythemia, Essential

    Study Results

    No Results Posted as of Sep 21, 2018