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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date August 26, 2016
First Posted Date September 8, 2016
Last Update Posted Date September 21, 2018
Actual Study Start Date December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02893410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Observance and Side Effects of Cytoreductive Drugs in PV and ET Patients
Official Title Etude de l'Observance thérapeutique et Des Effets Secondaires Des Traitements Chez Les Patients traités Pour Polyglobulie de Vaquez et thrombocytémie Essentielle
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with PV or ET who took oral or sub-cutaneous drugs to treat MPN disorders.
Condition
  • Polycythemia Vera
  • Essential Thrombocythemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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 associated with an increased risk of complications in patients with polycythemia vera or essential thrombocythemia (OUEST study). Haematologica. 2018 Apr;103(4):607-613. doi: 10.3324/haematol.2017.180448. Epub 2017 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2016)
286
Original Actual Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02893410
Other Study ID Numbers OUEST (RB14.115)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Study Director: Jean-Christophe Ianotto, MD CHRU de Brest
PRS Account University Hospital, Brest
Verification Date September 2018