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Completed

NCT Number: NCT01058044

Adherence to Oral Anticancer Treatment Using Electronic Monitoring System

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

    Time frame: everey visit during 6 months

Secondary outcomes

  1. evaluation of liberal nurse satisfaction

    Time frame: inclusion

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

    Time frame: during 6 months

  3. Patient satisfaction

    Time frame: 6 months

  4. drug interaction

    Time frame: during 6 months

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
First posted
Jan 28, 2010
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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