Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Evaluation of adherence to 3 oral anticancer treatment using a  Medication Event Monitoring System 


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adherence assessment group<br>evaluation of adherence using MEMS | Other: Evaluation of adherence to 3 oral anticancer treatment using a  Medication Event Monitoring System <br>* Evaluation of adherence using a  Medication Event Monitoring System  (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | everey visit during 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Sunitinib, capecitabine, anastrozole, letrozole, adherence, anticancer treatment