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interim analysis : discontinuation for efficacy of the intervention
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capecitabine | Other | patients treated by capecitabine alone (n=100) |
|
| capecitabine + lapatinib | Other | patients treated by capecitabine and lapatinib (n=100) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib | Other |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle VAN PRAAGH, MD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |