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

Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (Other)

Overall Status

Unknown status

CT.gov ID

NCT01370980

Collaborator

Centre Hospitalier Universitaire Vaudois (Other)

Enrollment

Location

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Cancer

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 Design

Study Type:

Observational

Anticipated 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 :

Jul 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in Medication adherence [3 months, 6 months, 9 months, 12 months]
MEMS data, completed by informations given in motivational interviewing

Secondary Outcome Measures

Program implementation [1 year]
Evaluating the implementation of the program in pharmacies
Oncologists, nurses, pharmacists and patients satisfaction [1 year]
By questionnaire and interviews
Effect of Adverse Drug Reaction (ADR) on medication adherence [1 year]
By MEMS data and motivational interviewing informations
Change in Adverse Drug Reaction (ADR) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV	Lausanne	Vaud	Switzerland	1010

Sponsors and Collaborators

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois

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