Clinical trial NCT00769080: The Performance of Patient Support Program in Early Stage Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: PSP
Standard Treatment
Standard Treatment plus PSP
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 524
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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


Eligibility 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)

Primary outcomes:
measure: compare the 1-year adherence
timeFrame: 1 year
Secondary outcomes:
measure: scores of Beliefs about Medicines Questionnaire (BMQ)
timeFrame: 1 year
measure: Scores in Patient Centred Care Questionnaire (PCCQ)
timeFrame: 1 year
measure: Morisky scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanning
country: China
facility: Research Site
state: Guangxi
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Emily Huang
role: STUDY_CHAIR
affiliation: Fudan University
name: Shen Zhenzhou, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.