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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370980
• Other study ID #: 139/10
• Status: Completed
• Start date: July 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2022
• Source: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Mouth Neoplasms

Locations

Country	Name	City	State
Switzerland	Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV	Lausanne	Vaud

Sponsors (2)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Medication adherence	MEMS data, completed by informations given in motivational interviewing	3 months, 6 months, 9 months, 12 months
Secondary	Program implementation	Evaluating the implementation of the program in pharmacies	1 year
Secondary	Oncologists, nurses, pharmacists and patients satisfaction	By questionnaire and interviews	1 year
Secondary	Effect of Adverse Drug Reaction (ADR) on medication adherence	By MEMS data and motivational interviewing informations	1 year
Secondary	Change in Adverse Drug Reaction (ADR)	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