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Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

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ClinicalTrials.gov Identifier: NCT01370980
Recruitment Status : Unknown
Verified July 2012 by Marie Schneider, Policlinique Médicale Universitaire.
Recruitment status was:  Recruiting
First Posted : June 10, 2011
Last Update Posted : July 17, 2012
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Marie Schneider, Policlinique Médicale Universitaire

Brief Summary:
The purpose of this study is to implement a support interdisciplinary program(oncologists, pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral oncology treatments. The aim is to ensure continuity of care between professionals,effectiveness of treatment and patient safety.

Condition or disease

Detailed Description:
80 patients will be included in swiss-romande hospitals and private oncologists and followed by thirty study pharmacies. Each refusal and drop-out will be documented. Follow-up duration is 48 weeks, with a motivational interviewing at least every three months. Patient adherence will be assessed electronically by MEMS (Medication Event Monitoring System).

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collaborative and Seamless Care in Oncology : a Study in Primary Care to Measure and Reinforce Safety and Adherence to Oral Cancer Treatment
Study Start Date : July 2010
Primary Completion Date : December 2011
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer
U.S. FDA Resources

Study population
Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox

Primary Outcome Measures :
  1. Change in Medication adherence [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    MEMS data, completed by informations given in motivational interviewing

Secondary Outcome Measures :
  1. Program implementation [ Time Frame: 1 year ]
    Evaluating the implementation of the program in pharmacies

  2. Oncologists, nurses, pharmacists and patients satisfaction [ Time Frame: 1 year ]
    By questionnaire and interviews

  3. Effect of Adverse Drug Reaction (ADR) on medication adherence [ Time Frame: 1 year ]
    By MEMS data and motivational interviewing informations

  4. Change in Adverse Drug Reaction (ADR) [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
    To evaluate the frequency and severity of ADR and the pharmacist's contribution to their management. Data from motivational interviewing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with cancer treated by oral medication in swiss-romande hospitals and private oncologists, and enrolled in the adherence program in one of the thirty studies pharmacies.

Inclusion Criteria:

  • 18 years and older
  • Treated for a cancer with oral medication (letrozol, exemestan,imatinib, sunitinib, nilotinib, everolimus, deferasirox)
  • French speaking

Exclusion Criteria:

- None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370980

Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV Recruiting
Lausanne, Vaud, Switzerland, 1010
Contact: Bugnon Olivier    +41 21 314 48 48    Olivier.Bugnon@hospvd.ch   
Contact: Schneider Marie-Paule    +41 21 314 48 46    Marie-Paule.Schneider@hospvd.ch   
Sponsors and Collaborators
Policlinique Médicale Universitaire
Centre Hospitalier Universitaire Vaudois
Study Chair: Bugnon Olivier, Professor Policlinique Médicale Universitaire
Study Chair: Lüthi François, Dr Clinique Bois-Cerf, Lausanne
Principal Investigator: Schneider Marie-Paule, PhD Policlinique Medicale Universitaire
Principal Investigator: Chevaux Bernard, Dr Centre Hospitalier Universitaire Vaudois
Principal Investigator: Troxler Stéphanie, PhD Student Policlinique Medicale Universitaire
Principal Investigator: Leila Achtari, MD Centre Hospitalier Univeristaire Vaudois

Responsible Party: Marie Schneider, Dr, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01370980     History of Changes
Other Study ID Numbers: 139/10
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Marie Schneider, Policlinique Médicale Universitaire:
Medication Adherence
Patient Compliance
Patient Acceptance of Health Care
Administration, Oral

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action