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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681122
First received: May 20, 2008
Last updated: October 13, 2011
Last verified: October 2011

May 20, 2008
October 13, 2011
May 2008
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681122 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Breast Cancer
Not Provided
  • 1
    Standard therapy
  • 2
    Standard therapy + educational material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2600
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Chile,   Colombia,   Croatia,   Czech Republic,   Finland,   France,   Greece,   Italy,   Peru,   Romania,   Sweden,   Switzerland,   Turkey,   United Kingdom,   Venezuela
 
NCT00681122
NIS-OEU-ARI-2007/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Neven, P. Prof. KUL
AstraZeneca
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP