Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

NCT01058044 | Completed

• 2 other identifiers: AU792RCB 2009-A00244-53
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• evaluation of liberal nurse satisfaction

  inclusion

• resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)

  during 6 months

• Patient satisfaction

  6 months

• drug interaction

  during 6 months

Study Arms (1)

adherence assessment group

EXPERIMENTAL

evaluation of adherence using MEMS

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

Interventions

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

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

adherence assessment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

FR (1)