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

Colorectal Cancer Clinical Trial

— ProMETheX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01847599
• Other study ID #: 2010-A01300-39
• Status: Terminated
• Phase: N/A
• First received: April 5, 2013
• Last updated: July 18, 2017
• Start date: September 6, 2011
• Est. completion date: July 2, 2017

Study information

• Verified date: July 2017
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: July 2, 2017
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient satisfaction to the educational program as determined by questionnaire		at the end of the educational program i.e. approximately during the week 27
Secondary	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)