Clinical trial NCT01847599: Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
Official title: Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Breast Cancer
Colorectal Cancer
Keywords: educational intervention
adherence
capecitabine
lapatinib
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
timeFrame: 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 outcomes:
measure: patient satisfaction to the educational program as determined by questionnaire
timeFrame: at the end of the educational program i.e. approximately during the week 27
measure: safety and tolerability as determined by adverse events frequency
timeFrame: for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients)
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Isabelle VAN PRAAGH, MD
role: PRINCIPAL_INVESTIGATOR
References: