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Completed

NCT Number: NCT00769080

The Performance of Patient Support Program in Early Stage Breast Cancer

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

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. compare the 1-year adherence

    Time frame: 1 year

Secondary outcomes

  1. scores of Beliefs about Medicines Questionnaire (BMQ)

    Time frame: 1 year

  2. Scores in Patient Centred Care Questionnaire (PCCQ)

    Time frame: 1 year

  3. Morisky scale

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ARI NIS

Important dates

Study start
2008
Study completion
2010
First posted
Oct 8, 2008
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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