NCT01370980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

June 3, 2011

Last Update Submit

November 21, 2022

Conditions

Keywords

Medication AdherencePatient CompliancePatient Acceptance of Health CareAdministration, OralCancerLetrozolExemestanImatinibSunitinibNilotinibEverolimusDeferasirox

Outcome Measures

Primary Outcomes (1)

  • Change in Medication adherence

    MEMS data, completed by informations given in motivational interviewing

    3 months, 6 months, 9 months, 12 months

Secondary Outcomes (4)

  • Program implementation

    1 year

  • Oncologists, nurses, pharmacists and patients satisfaction

    1 year

  • Effect of Adverse Drug Reaction (ADR) on medication adherence

    1 year

  • Change in Adverse Drug Reaction (ADR)

    3 months, 6 months, 9 months, 12 months

Study Arms (1)

Study population

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • years and older
  • Treated for a cancer with oral medication (letrozol, exemestan,imatinib, sunitinib, nilotinib, everolimus, deferasirox)
  • French speaking

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinique Médicale Universitaire and Centre pluridisciplinaire d'oncologie, CHUV

Lausanne, Canton of Vaud, 1010, Switzerland

Location

MeSH Terms

Conditions

NeoplasmsMedication AdherencePatient CompliancePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bugnon Olivier, Professor

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

    STUDY CHAIR
  • Lüthi François, Dr

    Clinique Bois-Cerf, Lausanne

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 10, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

September 1, 2014

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations