CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00681122
Collaborator
(none)
2,600
164
36
15.9
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
2600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
May 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Standard therapy |
|
| 2 Standard therapy + educational material |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Canberra | Australian Capital Territory | Australia | |
| 2 | Research Site | Coffs Harbour | New South Wales | Australia | |
| 3 | Research Site | Newcastle | New South Wales | Australia | |
| 4 | Research Site | Port Macquarie | New South Wales | Australia | |
| 5 | Research Site | Tweed Heads | New South Wales | Australia | |
| 6 | Research Site | Brisbane | Queensland | Australia | |
| 7 | Research Site | Nambour | Queensland | Australia | |
| 8 | Research Site | Toowoomba | Queensland | Australia | |
| 9 | Research Site | Hobart | Tasmania | Australia | |
| 10 | Research Site | St. Veit | Carinthia | Austria | |
| 11 | Research Site | Wolfsberg | Carinthia | Austria | |
| 12 | Research Site | Weiz | Styria | Austria | |
| 13 | Research Site | Linz | Upper Austria | Austria | |
| 14 | Research Site | Salzburg | Austria | ||
| 15 | Research Site | Vienna | Austria | ||
| 16 | Research Site | Aalst | Belgium | ||
| 17 | Research Site | Antwerpen | Belgium | ||
| 18 | Research Site | Arlon | Belgium | ||
| 19 | Research Site | Bonheiden | Belgium | ||
| 20 | Research Site | Bornem | Belgium | ||
| 21 | Research Site | Boussu | Belgium | ||
| 22 | Research Site | Brussels | Belgium | ||
| 23 | Research Site | Charleroi | Belgium | ||
| 24 | Research Site | Dendermonde | Belgium | ||
| 25 | Research Site | Edegem | Belgium | ||
| 26 | Research Site | Eupen | Belgium | ||
| 27 | Research Site | Geel | Belgium | ||
| 28 | Research Site | Gent | Belgium | ||
| 29 | Research Site | Geraardsbergen | Belgium | ||
| 30 | Research Site | Gilly | Belgium | ||
| 31 | Research Site | Haine St Paul | Belgium | ||
| 32 | Research Site | Leuven | Belgium | ||
| 33 | Research Site | Li?ge | Belgium | ||
| 34 | Research Site | Libramont | Belgium | ||
| 35 | Research Site | Namur | Belgium | ||
| 36 | Research Site | Oostende | Belgium | ||
| 37 | Research Site | Ottignies | Belgium | ||
| 38 | Research Site | Overpelt | Belgium | ||
| 39 | Research Site | Rocourt | Belgium | ||
| 40 | Research Site | Seraing | Belgium | ||
| 41 | Research Site | Tournai | Belgium | ||
| 42 | Research Site | Turnhout | Belgium | ||
| 43 | Research Site | Santiago | Metropolitana | Chile | |
| 44 | Research Site | Temuco | Novena Region | Chile | |
| 45 | Research Site | Medellin | Antioquia | Colombia | |
| 46 | Research Site | Barranquilla | Atlantico | Colombia | |
| 47 | Research Site | Bogota | Cundinamarca | Colombia | |
| 48 | Research Site | Neiva | Huila | Colombia | |
| 49 | Research Site | Pasto | Nari?o | Colombia | |
| 50 | Research Site | Cali | Valle | Colombia | |
| 51 | Research Site | Osijek | Croatia | ||
| 52 | Research Site | Rijeka | Croatia | ||
| 53 | Research Site | Zagreb | Croatia | ||
| 54 | Research Site | Hradec Kralove | Czech Republic | ||
| 55 | Research Site | Opava | Czech Republic | ||
| 56 | Research Site | Ostrava | Czech Republic | ||
| 57 | Research Site | Praha | Czech Republic | ||
| 58 | Research Site | Helsinki | Finland | ||
| 59 | Research Site | Tampere | Finland | ||
| 60 | Research Site | Aix En Provence | France | ||
| 61 | Research Site | Ales | France | ||
| 62 | Research Site | Annecy | France | ||
| 63 | Research Site | Arpajon | France | ||
| 64 | Research Site | Avignon | France | ||
| 65 | Research Site | Beauvais | France | ||
| 66 | Research Site | Bordeaux | France | ||
| 67 | Research Site | Brest | France | ||
| 68 | Research Site | Brive La Gaillarde | France | ||
| 69 | Research Site | Colmar | France | ||
| 70 | Research Site | Creteil | France | ||
| 71 | Research Site | Cucq | France | ||
| 72 | Research Site | Dechy | France | ||
| 73 | Research Site | Evreux | France | ||
| 74 | Research Site | GAP | France | ||
| 75 | Research Site | Grenoble | France | ||
| 76 | Research Site | Hyeres | France | ||
| 77 | Research Site | La Seyne Sur Mer | France | ||
| 78 | Research Site | Limoges | France | ||
| 79 | Research Site | Lyon | France | ||
| 80 | Research Site | Mareuil Les Meaux | France | ||
| 81 | Research Site | Marseille | France | ||
| 82 | Research Site | Mont de Marsan | France | ||
| 83 | Research Site | Mougins | France | ||
| 84 | Research Site | Nancy | France | ||
| 85 | Research Site | Nantes | France | ||
| 86 | Research Site | Narbonne | France | ||
| 87 | Research Site | Nice | France | ||
| 88 | Research Site | Nimes | France | ||
| 89 | Research Site | Perigueux | France | ||
| 90 | Research Site | Perpignan | France | ||
| 91 | Research Site | Quimper | France | ||
| 92 | Research Site | Reims | France | ||
| 93 | Research Site | Rennes | France | ||
| 94 | Research Site | Rouen | France | ||
| 95 | Research Site | Saint Brieux | France | ||
| 96 | Research Site | Saint Cyr Sur Loire | France | ||
| 97 | Research Site | Saint Gregoire | France | ||
| 98 | Research Site | Saint Jean | France | ||
| 99 | Research Site | Saint Mande | France | ||
| 100 | Research Site | Saint Nazaire | France | ||
| 101 | Research Site | Strasbourg | France | ||
| 102 | Research Site | Thonon Les Bains | France | ||
| 103 | Research Site | Toulon | France | ||
| 104 | Research Site | Toulouse | France | ||
| 105 | Research Site | Valence | France | ||
| 106 | Research Site | Vannes | France | ||
| 107 | Research Site | Villeneuve Sur Lot | France | ||
| 108 | Research Site | Patras | Achaia | Greece | |
| 109 | Research Site | Athens | Greece | ||
| 110 | Research Site | Piraeous | Greece | ||
| 111 | Research Site | Thessaloniki | Greece | ||
| 112 | Research Site | Trikala | Greece | ||
| 113 | Research Site | Lido di Camaiore | Lucca | Italy | |
| 114 | Research Site | Bologna | Italy | ||
| 115 | Research Site | Cosenza | Italy | ||
| 116 | Research Site | Pavia | Italy | ||
| 117 | Research Site | Roma | Italy | ||
| 118 | Research Site | Treviso | Italy | ||
| 119 | Research Site | Lima | Peru | ||
| 120 | Research Site | Piura | Peru | ||
| 121 | Research Site | Alba-Iulia | Romania | ||
| 122 | Research Site | Baia Mare | Romania | ||
| 123 | Research Site | Bucuresti | Romania | ||
| 124 | Research Site | Cluj-Napoca | Romania | ||
| 125 | Research Site | Oradea | Romania | ||
| 126 | Research Site | Suceava | Romania | ||
| 127 | Research Site | Karlskrona | Sweden | ||
| 128 | Research Site | Skellefte? | Sweden | ||
| 129 | Research Site | Stockholm | Sweden | ||
| 130 | Research Site | Baden | Switzerland | ||
| 131 | Research Site | Bern | Switzerland | ||
| 132 | Research Site | Lugano | Switzerland | ||
| 133 | Research Site | St. Gallen | Switzerland | ||
| 134 | Research Site | Zurich | Switzerland | ||
| 135 | Research Site | Ankara | Turkey | ||
| 136 | Research Site | Diyarbakir | Turkey | ||
| 137 | Research Site | Eskisehir | Turkey | ||
| 138 | Research Site | Gaziantep | Turkey | ||
| 139 | Research Site | Istanbul | Turkey | ||
| 140 | Research Site | Izmir | Turkey | ||
| 141 | Research Site | Kayseri | Turkey | ||
| 142 | Research Site | Konya | Turkey | ||
| 143 | Research Site | Malatya | Turkey | ||
| 144 | Research Site | Mersin | Turkey | ||
| 145 | Research Site | St Albans | Hertfordshire | United Kingdom | |
| 146 | Research Site | Brighton | United Kingdom | ||
| 147 | Research Site | Bristol | United Kingdom | ||
| 148 | Research Site | Cardiff | United Kingdom | ||
| 149 | Research Site | Cheltenham | United Kingdom | ||
| 150 | Research Site | Coventry | United Kingdom | ||
| 151 | Research Site | Dundee | United Kingdom | ||
| 152 | Research Site | Edinburgh | United Kingdom | ||
| 153 | Research Site | Glasgow | United Kingdom | ||
| 154 | Research Site | Liverpool | United Kingdom | ||
| 155 | Research Site | London | United Kingdom | ||
| 156 | Research Site | Macclesfield | United Kingdom | ||
| 157 | Research Site | Manchester | United Kingdom | ||
| 158 | Research Site | Northwood | United Kingdom | ||
| 159 | Research Site | Nottingham | United Kingdom | ||
| 160 | Research Site | Scarborough | United Kingdom | ||
| 161 | Research Site | Shrewsbury | United Kingdom | ||
| 162 | Research Site | York | United Kingdom | ||
| 163 | Research Site | Caracas | Distrito Capital | Venezuela | |
| 164 | Research Site | Valencia | Estado Carabobo | Venezuela |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Neven, P. Prof., KUL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681122
Other Study ID Numbers:
- NIS-OEU-ARI-2007/1
First Posted:
May 21, 2008
Last Update Posted:
Jan 18, 2016
Last Verified:
Oct 1, 2011
Keywords provided by AstraZeneca
Additional relevant MeSH terms: