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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00681122

Acronym

CARIATIDE

Enrollment

2600

Registered

2008-05-21

Start date

2008-05-31

Completion date

2011-05-31

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, hormone therapy, aromatase inhibitor

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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:	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.	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.	After one and two years

Countries

Australia, Austria, Belgium, Chile, Colombia, Croatia, Czechia, Finland, France, Greece, Italy, Peru, Romania, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela

Outcome results