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


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer, Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib

Outcome Description:

the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system

Outcome Time Frame:

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)

Safety Issue:

No

Principal Investigator

Isabelle VAN PRAAGH, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Jean Perrin

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2010-A01300-39

NCT ID:

NCT01847599

Start Date:

September 2011

Completion Date:

February 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Colorectal Cancer
  • educational intervention
  • adherence
  • capecitabine
  • lapatinib
  • Breast Neoplasms
  • Colorectal Neoplasms

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