Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

NCT ID: NCT01058044

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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Cancer, Sunitinib, capecitabine, anastrozole, letrozole adherence, anticancer treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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adherence assessment group

evaluation of adherence using MEMS

Group Type EXPERIMENTAL

Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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RCB 2009-A00244-53

Identifier Type: OTHER

Identifier Source: secondary_id

AU792

Identifier Type: -

Identifier Source: org_study_id