Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment
This study is currently recruiting participants.
Verified July 2012 by Policlinique Médicale Universitaire
Sponsor:
Policlinique Médicale Universitaire
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
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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 |
|---|
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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 |
|---|
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Study population
Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox
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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
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 May 22, 2013