Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib

Not Applicable

Terminated

• Conditions: Metastatic Breast Cancer; Colorectal Cancer
• Interventions: Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib

• Registration Number: NCT01847599
• Lead Sponsor: Centre Jean Perrin

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.

Study Timeline

• Study Start: 2011-09-06
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Primary Completion: 2016-10-13
• Status Verified: 2017-07
• Study Completion: 2017-07-02
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capecitabine + lapatinib	Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib	patients treated by capecitabine and lapatinib (n=100)
capecitabine	Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib	patients treated by capecitabine alone (n=100)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France