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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Centre Jean Perrin
Clermont-Ferrand, France
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
Time frame: 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)
patient satisfaction to the educational program as determined by questionnaire
Time frame: at the end of the educational program i.e. approximately during the week 27
safety and tolerability as determined by adverse events frequency
Time frame: for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.