Trial record 2 of 235 for:
impact of educational material
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach) (CARIATIDE)
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| ClinicalTrials.gov Identifier: NCT00681122 |
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Recruitment Status :
Completed
First Posted : May 21, 2008
Last Update Posted : January 18, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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 |
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| Breast Cancer |
| Study Type : | Observational |
| Estimated 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 2008 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | May 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Group/Cohort |
|---|
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1
Standard therapy
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2
Standard therapy + educational material
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Primary Outcome Measures :
- 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 ]
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: [ Time Frame: 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681122
Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Neven, P. Prof. | KUL |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00681122 |
| Other Study ID Numbers: |
NIS-OEU-ARI-2007/1 |
| First Posted: | May 21, 2008 Key Record Dates |
| Last Update Posted: | January 18, 2016 |
| Last Verified: | October 2011 |
Keywords provided by AstraZeneca:
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Breast Cancer hormone therapy aromatase inhibitor |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |