Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centre Jean Perrin

ClinicalTrials.gov Identifier:

NCT01058044

First received: January 27, 2010

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 27, 2010
Last Updated Date	August 8, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2010)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01058044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2010)	evaluation of liberal nurse satisfaction [ Time Frame: inclusion ] [ Designated as safety issue: No ] resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy) [ Time Frame: during 6 months ] [ Designated as safety issue: No ] Patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ] drug interaction [ Time Frame: during 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
Official Title ^ICMJE	A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Cancer
Intervention ^ICMJE	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
Study Arm (s)	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 "
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	33
Completion Date	Not Provided
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01058044
Other Study ID Numbers ^ICMJE	AU792, RCB 2009-A00244-53
Has Data Monitoring Committee	No
Responsible Party	Centre Jean Perrin
Study Sponsor ^ICMJE	Centre Jean Perrin
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Jean Perrin
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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