Clinical trial NCT01370980: Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Medication Adherence
Patient Compliance
Patient Acceptance of Health Care
Administration, Oral
Cancer
Letrozol
Exemestan
Imatinib
Sunitinib
Nilotinib
Everolimus
Deferasirox
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2011-06-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Change in Medication adherence
timeFrame: 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Program implementation
timeFrame: 1 year
measure: Oncologists, nurses, pharmacists and patients satisfaction
timeFrame: 1 year
measure: Effect of Adverse Drug Reaction (ADR) on medication adherence
timeFrame: 1 year
measure: Change in Adverse Drug Reaction (ADR)
timeFrame: 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Bugnon Olivier, Professor
role: STUDY_CHAIR
affiliation: Clinique Bois-Cerf, Lausanne
name: Lüthi François, Dr
role: STUDY_CHAIR
affiliation: Policlinique Medicale Universitaire
name: Schneider Marie-Paule, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Chevaux Bernard, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinique Medicale Universitaire
name: Troxler Stéphanie, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Univeristaire Vaudois
name: Leila Achtari, MD
role: PRINCIPAL_INVESTIGATOR
References: