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

  • Switzerland
    • 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.

Sponsor

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

Collaborators

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

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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