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

Centre Jean Perrin

Status

Terminated

Conditions

Metastatic Breast Cancer

Colorectal Cancer

Treatments

Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01847599

2010-A01300-39

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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