Colorectal Cancer, Metastatic Breast Cancer
Conditions
Keywords
educational intervention, adherence, capecitabine, lapatinib
Brief summary
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
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.
Interventions
OTHEREducational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
Sponsors
Centre Jean Perrin
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib | 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) | the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system |
Secondary
| Measure | 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) |
Countries
France
Outcome results
None listed