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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Policlinique Médicale Universitaire
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Marie Schneider, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier:
NCT01370980
First received: June 3, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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
Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Policlinique Médicale Universitaire:

Primary Outcome Measures:
  • Change in Medication adherence [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
    MEMS data, completed by informations given in motivational interviewing


Secondary Outcome Measures:
  • Program implementation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluating the implementation of the program in pharmacies

  • Oncologists, nurses, pharmacists and patients satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    By questionnaire and interviews

  • Effect of Adverse Drug Reaction (ADR) on medication adherence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    By MEMS data and motivational interviewing informations

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


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study population
Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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

  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: NCT01370980

Locations
Switzerland
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
Investigators
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
  More Information

No publications provided

Responsible Party: Marie Schneider, Dr, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01370980     History of Changes
Other Study ID Numbers: 139/10
Study First Received: June 3, 2011
Last Updated: July 16, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Policlinique Médicale Universitaire:
Medication Adherence
Patient Compliance
Patient Acceptance of Health Care
Administration, Oral
Cancer
Letrozol
Exemestan
Imatinib
Sunitinib
Nilotinib
Everolimus
Deferasirox

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 23, 2014