CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach) (CARIATIDE)

January 15, 2016 updated by: AstraZeneca

An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman

This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2600

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

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Research Site
    • New South Wales
      • Coffs Harbour, New South Wales, Australia
        • Research Site
      • Newcastle, New South Wales, Australia
        • Research Site
      • Port Macquarie, New South Wales, Australia
        • Research Site
      • Tweed Heads, New South Wales, Australia
        • Research Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site
      • Nambour, Queensland, Australia
        • Research Site
      • Toowoomba, Queensland, Australia
        • Research Site
    • Tasmania
      • Hobart, Tasmania, Australia
        • Research Site
  • Austria
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
    • Carinthia
      • St. Veit, Carinthia, Austria
        • Research Site
      • Wolfsberg, Carinthia, Austria
        • Research Site
    • Styria
      • Weiz, Styria, Austria
        • Research Site
    • Upper Austria
      • Linz, Upper Austria, Austria
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Antwerpen, Belgium
        • Research Site
      • Arlon, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Bornem, Belgium
        • Research Site
      • Boussu, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Dendermonde, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Eupen, Belgium
        • Research Site
      • Geel, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Geraardsbergen, Belgium
        • Research Site
      • Gilly, Belgium
        • Research Site
      • Haine St Paul, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Li?ge, Belgium
        • Research Site
      • Libramont, Belgium
        • Research Site
      • Namur, Belgium
        • Research Site
      • Oostende, Belgium
        • Research Site
      • Ottignies, Belgium
        • Research Site
      • Overpelt, Belgium
        • Research Site
      • Rocourt, Belgium
        • Research Site
      • Seraing, Belgium
        • Research Site
      • Tournai, Belgium
        • Research Site
      • Turnhout, Belgium
        • Research Site
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Research Site
    • Novena Region
      • Temuco, Novena Region, Chile
        • Research Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Research Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Research Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Research Site
    • Huila
      • Neiva, Huila, Colombia
        • Research Site
    • Nari?o
      • Pasto, Nari?o, Colombia
        • Research Site
    • Valle
      • Cali, Valle, Colombia
        • Research Site
  • Croatia
      • Osijek, Croatia
        • Research Site
      • Rijeka, Croatia
        • Research Site
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Research Site
      • Opava, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • France
      • Aix En Provence, France
        • Research Site
      • Ales, France
        • Research Site
      • Annecy, France
        • Research Site
      • Arpajon, France
        • Research Site
      • Avignon, France
        • Research Site
      • Beauvais, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Brest, France
        • Research Site
      • Brive La Gaillarde, France
        • Research Site
      • Colmar, France
        • Research Site
      • Creteil, France
        • Research Site
      • Cucq, France
        • Research Site
      • Dechy, France
        • Research Site
      • Evreux, France
        • Research Site
      • GAP, France
        • Research Site
      • Grenoble, France
        • Research Site
      • Hyeres, France
        • Research Site
      • La Seyne Sur Mer, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lyon, France
        • Research Site
      • Mareuil Les Meaux, France
        • Research Site
      • Marseille, France
        • Research Site
      • Mont de Marsan, France
        • Research Site
      • Mougins, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nantes, France
        • Research Site
      • Narbonne, France
        • Research Site
      • Nice, France
        • Research Site
      • Nimes, France
        • Research Site
      • Perigueux, France
        • Research Site
      • Perpignan, France
        • Research Site
      • Quimper, France
        • Research Site
      • Reims, France
        • Research Site
      • Rennes, France
        • Research Site
      • Rouen, France
        • Research Site
      • Saint Brieux, France
        • Research Site
      • Saint Cyr Sur Loire, France
        • Research Site
      • Saint Gregoire, France
        • Research Site
      • Saint Jean, France
        • Research Site
      • Saint Mande, France
        • Research Site
      • Saint Nazaire, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Thonon Les Bains, France
        • Research Site
      • Toulon, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Valence, France
        • Research Site
      • Vannes, France
        • Research Site
      • Villeneuve Sur Lot, France
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Piraeous, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Trikala, Greece
        • Research Site
    • Achaia
      • Patras, Achaia, Greece
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Cosenza, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Treviso, Italy
        • Research Site
    • Lucca
      • Lido di Camaiore, Lucca, Italy
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
      • Piura, Peru
        • Research Site
  • Romania
      • Alba-Iulia, Romania
        • Research Site
      • Baia Mare, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj-Napoca, Romania
        • Research Site
      • Oradea, Romania
        • Research Site
      • Suceava, Romania
        • Research Site
  • Sweden
      • Karlskrona, Sweden
        • Research Site
      • Skellefte?, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • Switzerland
      • Baden, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site
      • Lugano, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Zurich, Switzerland
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Diyarbakir, Turkey
        • Research Site
      • Eskisehir, Turkey
        • Research Site
      • Gaziantep, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Kayseri, Turkey
        • Research Site
      • Konya, Turkey
        • Research Site
      • Malatya, Turkey
        • Research Site
      • Mersin, Turkey
        • Research Site
  • United Kingdom
      • Brighton, United Kingdom
        • Research Site
      • Bristol, United Kingdom
        • Research Site
      • Cardiff, United Kingdom
        • Research Site
      • Cheltenham, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Macclesfield, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Northwood, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Scarborough, United Kingdom
        • Research Site
      • Shrewsbury, United Kingdom
        • Research Site
      • York, United Kingdom
        • Research Site
    • Hertfordshire
      • St Albans, Hertfordshire, United Kingdom
        • Research Site
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela
        • Research Site
    • Estado Carabobo
      • Valencia, Estado Carabobo, Venezuela
        • Research Site

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

Female

Sampling Method

Probability Sample

Study Population

Postmenopausal women with hormone sensitive early breast cancer that have been prescribed adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The adjuvant AI medication must not have exceeded thirteen weeks of treatment duration.

Description

Inclusion Criteria:

  • Postmenopausal woman with hormone sensitive early breast cancer
  • Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks

Exclusion Criteria:

  • Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
  • Concomitant adjuvant treatment with tamoxifen or exemestane
  • Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Standard therapy
2
Standard therapy + educational material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
Time Frame: once after one year
once after one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:
Time Frame: After one and two years.
After one and two years.
Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.
Time Frame: After one and two years
After one and two years
Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.
Time Frame: After one and two years
After one and two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Neven, P. Prof., KUL

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

May 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OEU-ARI-2007/1

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.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe