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

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ClinicalTrials.gov Identifier: NCT02893410
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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
Polycythemia Vera Essential Thrombocythemia

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.


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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 : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015





Primary Outcome Measures :
  1. Rate of adherence to drug prescription [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with PV or ET who took oral or sub-cutaneous drugs to treat MPN disorders.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893410


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Study Director: Jean-Christophe Ianotto, MD CHRU de Brest

Publications of Results:
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02893410     History of Changes
Other Study ID Numbers: OUEST (RB14.115)
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Polycythemia
Polycythemia Vera
Thrombocytosis
Thrombocythemia, Essential
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders