The Performance of Patient Support Program in Early Stage Breast Cancer
ARI NIS
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
1 other identifier
observational
524
1 country
13
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 29, 2011
November 1, 2011
October 6, 2008
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compare the 1-year adherence
1 year
Secondary Outcomes (3)
scores of Beliefs about Medicines Questionnaire (BMQ)
1 year
Scores in Patient Centred Care Questionnaire (PCCQ)
1 year
Morisky scale
1 year
Study Arms (2)
1
Standard Treatment plus PSP
2
Standard Treatment
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Beijing, Beijing Municipality, China
Research Site
Chongqing, Chongqing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Nanning, Guangxi, China
Research Site
Harbin, Heilongjiang, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Qingdao, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Hangzhou, Zhejiang, China
Related Publications (1)
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. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12.
PMID: 22527106DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karen Atkin
AstraZeneca
- STUDY CHAIR
Emily Huang
AstraZeneca
- PRINCIPAL INVESTIGATOR
Shen Zhenzhou, Prof
Fudan University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2008
First Posted
October 8, 2008
Study Start
September 1, 2008
Study Completion
October 1, 2010
Last Updated
November 29, 2011
Record last verified: 2011-11