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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 16, 2013