- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370980
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment
November 21, 2022 updated by: Marie Schneider, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborative and Seamless Care in Oncology : a Study in Primary Care to Measure and Reinforce Safety and Adherence to Oral Cancer Treatment
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1010
- Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Study population
Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Medication adherence
Time Frame: 3 months, 6 months, 9 months, 12 months
|
MEMS data, completed by informations given in motivational interviewing
|
3 months, 6 months, 9 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program implementation
Time Frame: 1 year
|
Evaluating the implementation of the program in pharmacies
|
1 year
|
Oncologists, nurses, pharmacists and patients satisfaction
Time Frame: 1 year
|
By questionnaire and interviews
|
1 year
|
Effect of Adverse Drug Reaction (ADR) on medication adherence
Time Frame: 1 year
|
By MEMS data and motivational interviewing informations
|
1 year
|
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.
|
3 months, 6 months, 9 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Bugnon Olivier, Professor, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
June 3, 2011
First Submitted That Met QC Criteria
June 9, 2011
First Posted (Estimate)
June 10, 2011
Study Record Updates
Last Update Posted (Actual)
November 22, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 139/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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