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Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058044
First Posted: January 28, 2010
Last Update Posted: August 9, 2012
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.
Information provided by (Responsible Party):
Centre Jean Perrin
January 27, 2010
January 28, 2010
August 9, 2012
July 2009
January 2011   (Final data collection date for primary outcome measure)
evaluation of adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. [ Time Frame: everey visit during 6 months ]
Same as current
Complete list of historical versions of study NCT01058044 on ClinicalTrials.gov Archive Site
  • evaluation of liberal nurse satisfaction [ Time Frame: inclusion ]
  • resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy) [ Time Frame: during 6 months ]
  • Patient satisfaction [ Time Frame: 6 months ]
  • drug interaction [ Time Frame: during 6 months ]
Same as current
Not Provided
Not Provided
 
Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Cancer
Other: Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "
Evaluation of adherence using a " Medication Event Monitoring System " (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy
Experimental: adherence assessment group
evaluation of adherence using MEMS
Intervention: Other: Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • histologically proven malignant tumor
  • documented decision of treatment with i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor
  • ambulatory treated subject
  • Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
  • Written informed consent

Exclusion Criteria:

  • any severe concomitant wich makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
  • patient who does not agreed to participate the program
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01058044
AU792
RCB 2009-A00244-53 ( Other Identifier: France: Afssaps - French Health Products Safety Agency )
No
Not Provided
Not Provided
Centre Jean Perrin
Centre Jean Perrin
Not Provided
Not Provided
Centre Jean Perrin
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP