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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
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • compare the 1-year adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 524
Study Start Date: September 2008
Study Completion Date: October 2010
Groups/Cohorts
1
Standard Treatment plus PSP
2
Standard Treatment

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769080

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Chongqing
Research Site
Chongqing, Chongqing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Guangxi
Research Site
Nanning, Guangxi, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shandong
Research Site
Qingdao, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Atkin AstraZeneca
Study Chair: Emily Huang AstraZeneca
Principal Investigator: Shen Zhenzhou, Prof Fudan University
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00769080     History of Changes
Other Study ID Numbers: NIS-OCN-ARI-2008/1
Study First Received: October 6, 2008
Last Updated: November 28, 2011
Health Authority: China: Ethics Committee

Keywords provided by AstraZeneca:
PSP
Standard Treatment
Standard Treatment plus PSP

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013