Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With 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.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
No
Isabelle VAN PRAAGH, MD
Principal Investigator
Centre Jean Perrin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2010-A01300-39
NCT01847599
September 2011
February 2014
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