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The Performance of Patient Support Program in Early Stage Breast Cancer (ARI NIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00769080
First received: October 6, 2008
Last updated: November 28, 2011
Last verified: November 2011
History of Changes

October 6, 2008
November 28, 2011
September 2008
Not Provided
compare the 1-year adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769080 on ClinicalTrials.gov Archive Site
  • scores of Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Scores in Patient Centred Care Questionnaire (PCCQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Morisky scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Performance of Patient Support Program in Early Stage Breast Cancer
A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer

The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year
Not Provided
Observational
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Postmenopausal women with hormone sensitive early breast cancers to whom have been prescribed upfront adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The upfront AI medication must not have exceeded eight weeks.
Breast Cancer
Not Provided
  • 1
    Standard Treatment plus PSP
  • 2
    Standard Treatment
Yu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. Epub 2012 Apr 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
524
October 2010
Not Provided

Inclusion Criteria:

  • Provide signed and dated written Informed Consent
  • Have been taking upfront AI adjuvant therapy in line with current SmPC
  • Be capable of completing drug intake by herself
  • Be capable of understanding Chinese

Exclusion Criteria:

  • Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
  • Upfront adjuvant AI medication which has exceeded over eight weeks
  • Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00769080
NIS-OCN-ARI-2008/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Karen Atkin AstraZeneca
Study Chair: Emily Huang AstraZeneca
Principal Investigator: Shen Zhenzhou, Prof Fudan University
AstraZeneca
November 2011

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