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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1
Standard therapy
2
Standard therapy + educational material

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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