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

Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- 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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: capecitabine; patients treated by capecitabine alone (n=100)	Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
Other: capecitabine + lapatinib; patients treated by capecitabine and lapatinib (n=100)	Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Isabelle VAN PRAAGH, MD, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2011
• Primary Completion (Actual): October 13, 2016
• Study Completion (Actual): July 2, 2017

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: capecitabine; adherence; lapatinib; educational intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Lapatinib
• Other Study ID Numbers: 2010-A01300-39