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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00769080

Acronym

ARI NIS

Enrollment

524

Registered

2008-10-08

Start date

2008-09-30

Completion date

2010-10-31

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

PSP, Standard Treatment, Standard Treatment plus PSP

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
compare the 1-year adherence	1 year

Secondary

Measure	Time frame
scores of Beliefs about Medicines Questionnaire (BMQ)	1 year
Scores in Patient Centred Care Questionnaire (PCCQ)	1 year
Morisky scale	1 year

Countries

China

Outcome results