Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

Cancer Clinical Trial

Official title:

A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058044
• Other study ID #: AU792
• Secondary ID: RCB 2009-A00244-
• Status: Completed
• Phase: N/A
• First received: January 27, 2010
• Last updated: August 8, 2012
• Start date: July 2009

Study information

• Verified date: August 2012
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• histologically proven malignant tumor

• documented decision of treatment with i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor

• ambulatory treated subject

• Subject who accept to use MEMS monitors to automatically compile their drug dosing histories

• Written informed consent

Exclusion Criteria:

• any severe concomitant wich makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol

• patient who does not agreed to participate the program

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "
Evaluation of adherence using a " Medication Event Monitoring System " (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy

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 adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.		everey visit during 6 months	No
Secondary	evaluation of liberal nurse satisfaction		inclusion	No
Secondary	resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)		during 6 months	No
Secondary	Patient satisfaction		6 months	No
Secondary	drug interaction		during 6 months	No