The Performance of Patient Support Program in Early Stage Breast Cancer

Breast Cancer Clinical Trial

— ARI NIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769080
• Other study ID #: NIS-OCN-ARI-2008/1
• Status: Completed
• Phase: N/A
• First received: October 6, 2008
• Last updated: November 28, 2011
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Harbin	Heilongjiang
China	Research Site	Nanjing	Jiangsu
China	Research Site	Nanning	Guangxi
China	Research Site	Qingdao	Shandong
China	Research Site	Shanghai	Shanghai
China	Research Site	Tianjin	Tianjin
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the 1-year adherence		1 year	No
Secondary	scores of Beliefs about Medicines Questionnaire (BMQ)		1 year	No
Secondary	Scores in Patient Centred Care Questionnaire (PCCQ)		1 year	No
Secondary	Morisky scale		1 year	No