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Clinical Trials/NCT01058044
NCT01058044
Completed
Not Applicable

A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

Centre Jean Perrin1 site in 1 country33 target enrollmentJuly 2009
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre Jean Perrin
Enrollment
33
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
January 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Jean Perrin
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • evaluation of liberal nurse satisfaction(inclusion)
  • resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)(during 6 months)
  • Patient satisfaction(6 months)
  • drug interaction(during 6 months)

Study Sites (1)

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