Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.

Detailed Description
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200 subjects who meet the inclusion/exclusion criteria treated by capecitabine +/- lapatinib, will be enrolled into the study. Adherence to treatment of all subjects will be assessed during a first adherence evaluation period of 3 cycles in order to identify patients who need educational intervention(non adherent patients). Only nonadherent patients (adherence rate < 80%) will receive an education intervention. During the educational program, the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib will be evaluated for the 6 subsequent cycles.

Official Title
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Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib

Conditions
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Metastatic Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years histologically confirmed breast cancer or colorectal cancer Patient starting oral treatment : capecitabine alone or in combination with lapatinib (can be included before the first cycle or during the first 2 cycles). Volunteer to participate in the study. ambulatory treated patient Able to read, write and understand French. Subject who accept to use MEMS monitors to automatically compile their drug dosing histories Written informed consent Exclusion Criteria: more than 3 metastatic chemotherapies any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: capecitabine<br>patients treated by capecitabine alone (n=100) | Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib<br> <br> |
| Other: capecitabine + lapatinib<br>patients treated by capecitabine and lapatinib (n=100) | Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib | the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system | every visit during 3 cycles i.e. 9 weeks (adherent patients) and for 6 additional cycles i.e. 18 weeks during educational intervention (nonadhererent patients) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction to the educational program as determined by questionnaire |  | at the end of the educational program i.e. approximately during the week 27 | 
| safety and tolerability as determined by adverse events frequency |  | for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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educational intervention, adherence, capecitabine, lapatinib