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
| Tracking Information | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 3, 2011 | ||||||||||||||||||||||||
| Last Updated Date | July 16, 2012 | ||||||||||||||||||||||||
| Start Date ICMJE | July 2010 | ||||||||||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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 |
||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01370980 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment | ||||||||||||||||||||||||
| Official Title ICMJE | Collaborative and Seamless Care in Oncology : a Study in Primary Care to Measure and Reinforce Safety and Adherence to Oral Cancer Treatment | ||||||||||||||||||||||||
| 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. |
||||||||||||||||||||||||
| 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 ICMJE | Observational | ||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||||||
| 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. |
||||||||||||||||||||||||
| Condition ICMJE | Cancer | ||||||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||
| Study Group/Cohort (s) | Study population
Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox |
||||||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||||||||||||||||||
| Estimated Completion Date | September 2014 | ||||||||||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - None |
||||||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Not Provided | ||||||||||||||||||||||||
| Location Countries ICMJE | Switzerland | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT01370980 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 139/10 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Marie Schneider, Policlinique Médicale Universitaire | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Policlinique Médicale Universitaire | ||||||||||||||||||||||||
| Collaborators ICMJE | Centre Hospitalier Universitaire Vaudois | ||||||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||||||
| Information Provided By | Policlinique Médicale Universitaire | ||||||||||||||||||||||||
| Verification Date | July 2012 | ||||||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||||||