Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01058044
First received: January 27, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • 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. [ Time Frame: everey visit during 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluation of liberal nurse satisfaction [ Time Frame: inclusion ] [ Designated as safety issue: No ]
  • resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy) [ Time Frame: during 6 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • drug interaction [ Time Frame: during 6 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: July 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adherence assessment group
evaluation of adherence using MEMS
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058044

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
  More Information

No publications provided

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01058044     History of Changes
Other Study ID Numbers: AU792, RCB 2009-A00244-53
Study First Received: January 27, 2010
Last Updated: August 8, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Jean Perrin:
Cancer, Sunitinib, capecitabine, anastrozole, letrozole
adherence, anticancer treatment

ClinicalTrials.gov processed this record on September 30, 2014